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

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.

• Brand Name: SPACELABS TELEMETRY RECEIVER MODULE
• Type of Device: TELEMETRY 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 Key: 5449364
• MDR Text Key: 38632547
• Report Number: 3010157426-2016-00016
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90478
• Other Device ID Number: 3.05.07EN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Death