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

Model Number 90478

Device Problem Device Alarm System (1012)

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 05/21/2015

Event Type  Death  

Event Description

Spacelabs received a report that on (b)(6) 2015 at 9:30 a.M., a patient experienced a low heart rate and the telemetry central monitor (model 91387-38) did not sound an alarm until the patient was in a lethal arrhythmia.The patient was a ¿do not resuscitate¿ and passed away later the same day.The facility nurse manager stated the patient death was not device related.The patient was also monitored with telemetry transmitter model 91347 and receiver module model 90478.

Manufacturer Narrative

Onsite testing of the involved devices by a spacelabs field service engineer was declined by the customer since they were unable to locate the devices.Spacelabs has launched an investigation into this event and will file a supplemental report when the investigation is complete.Placeholder.

Manufacturer Narrative

Onsite testing of the involved devices by a spacelabs field service engineer was declined by the customer since they were unable to locate the devices.The customer did not provide the patient retrospective database when asked.The customer did provide a compressed waveform printout, a screen capture of the latest alarm thumbnails and a screen capture of the alarm review drop down list showing the last 29 alarms (all from clinical access) as well as alarm settings and error logs for review.A review of the clinical access data by a product specialist confirmed the presence of a low heart rate alarm which transitioned into an asystole alarm.There was no product malfunction.This report is considered final and the issue closed.Placeholder.

• 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: 4843209
• MDR Text Key: 5939148
• Report Number: 3010157426-2015-00123
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2007
• Device Model Number: 90478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 06/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2006
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Death