Vocera Badge auto-acknowledged second critical alarm notification when two arrived within seconds, leaving nurse unaware of second patient's desaturation
[MALFUNCTION]Apr 22, 2019 · Vocera Communications · Vocera Badge · United States (multiple hotel chains)
Failure Mode
MALFUNCTION
Event Date
Apr 22, 2019
Primary Entity
Vocera Communications
Robotic Platform
Vocera Badge
Jurisdiction / Location
United States (multiple hotel chains)
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
Two patients cared for by the same nurse had critical desaturations within seconds of one another. The monitoring system routed alarm notifications for both patients to the same Vocera badge, but the badge did not enunciate the second notification or require a separate acknowledgement. When the nurse acknowledged the first alarm, the second was automatically cancelled.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8591239&pc=MSX
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8591239&pc=MSX
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Details
Incident Context & FAQ
What happened in Vocera Badge auto-acknowledged second critical alarm notification when two arrived within seconds, leaving nurse unaware of second patient's desaturation?
Two patients cared for by the same nurse had critical desaturations within seconds of one another. The monitoring system routed alarm notifications for both patients to the same Vocera badge, but the badge did not enunciate the second notification or require a separate acknowledgement. When the nurse acknowledged the first alarm, the second was automatically cancelled. A passing staff member heard the room alarm and responded, preventing patient harm. Vocera validated the issue. The event was recreated by pulling two code blue buttons simultaneously.
When did this incident occur?
The incident is recorded as occurring on April 22, 2019 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Vocera Badge auto-acknowledged second critical alarm notification when two arrived within seconds, leaving nurse unaware of second patient's desaturation?
Vocera Badge by Vocera Communications is the recorded robot involved in this incident at United States (multiple hotel chains).
Has anyone responded to Vocera Badge auto-acknowledged second critical alarm notification when two arrived within seconds, leaving nurse unaware of second patient's desaturation?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Vocera Badge auto-acknowledged second critical alarm notification when two arrived within seconds, leaving nurse unaware of second patient's desaturation?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.