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

Model Number 90478

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 06/02/2016

Event Type  Death  

Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report when the investigation is complete.

Event Description

Spacelabs received a report that telemetry monitor model 90478 failed to alarm for asystole on (b)(6) 2016.The patient expired the same date.

Manufacturer Narrative

The patient's historical waveforms and trend information (in the ics database) was collected by the fse and sent to spacelabs for analysis.Using the database information, investigators were able to determine that telemetry received signal quality and amplitude were poor after the lead wires were disconnected and reconnected to the patient.Persistent poorly defined signal is consistent with conditions such as the drying of electrodes over time on a patient¿s body.The clinical parameters operations manual notes that ¿silver/silver chloride electrodes should be used, patient¿s skin should be properly prepared, all electrodes are firmly attached and in good condition, positioned on a flat, non-muscular area, and ensure that lead wires are properly fastened and in good condition.¿ after testing the device and interpreting the data, it is determined that the device did not malfunction and did perform to specification.We suspect that the flat-line waveform associated with a poorly defined signal may have been misinterpreted by the clinician as asystole as the waveform data reviewed showed no episode of asystole near the time of the alleged event.This report is considered final and the issue is 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: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 5758419
• MDR Text Key: 48437628
• Report Number: 3010157426-2016-00038
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90478
• Other Device ID Number: 3.05.07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 81 YR
• Patient Weight: 65