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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECEIVER MODULE

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SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECEIVER MODULE Back to Search Results
Model Number 90478
Device Problem Device Alarm System (1012)
Patient Problems Death (1802); Ventricular Fibrillation (2130)
Event Date 01/18/2016
Event Type  Death  
Manufacturer Narrative

Onsite inspection of the involved devices conducted by a spacelabs field service engineer confirmed the equipment performed to specifications. Spacelabs has launched an investigation of this event and will file a supplemental report once the investigation is complete.

 
Event Description

Spacelabs received a report that on january 18, 2016 a patient, monitored with telemetry receiver module model 90478 and central monitor model 91387-38, experienced ventricular fibrillation that did not generate an alarm. The patient passed away subsequent to this event.

 
Manufacturer Narrative

The customer provided patient retrospective database was reviewed by spacelabs engineering. The data confirmed that at 01:28:49am on (b)(6) the patient¿s pacemaker ceased firing when the intrinsic heart rate increased above 90 bpm. At 01:29:03am the monitoring system began generating a long series of high priority alarms for high heart rate, vfib, run, and low heart rate. The alarm condition identified in the complaint was confirmed to have been correctly classified and documented in the retrospective database. The monitor's alarm indicators operated according to specifications when tested by spacelabs field service engineer. In conclusion, we are unable to identify any technical problems that would have resulted in a failure of the alarm systems, and to reproduce the reported failure. This report is considered final and the issue closed.

 
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Brand NameSPACELABS TELEMETRY RECEIVER MODULE
Type of DeviceTELEMETRY RECEIVER MODULE
Manufacturer (Section D)
SPACELABS HEALTHCARE INC.
35301 se center st.
snoqualmie WA 98065
Manufacturer Contact
john zeng
35301 se center st.
snoqualmie, WA 98065
4253635915
MDR Report Key5449364
MDR Text Key38632547
Report Number3010157426-2016-00016
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK925510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number90478
OTHER Device ID Number3.05.07EN
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/19/2016 Patient Sequence Number: 1
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