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

Model Number 90478

Device Problem Device Alarm System (1012)

Patient Problem Ventricular Tachycardia (2132)

Event Date 09/07/2017

Event Type  malfunction  

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 on (b)(6) 2017 a telemetry patient experienced an episode of ventricular tachycardia (vtach) or a vrun that an alarm did not occur at the central monitor.No one was injured as a result of this event.

Manufacturer Narrative

Onsite testing by a spacelabs field service engineer confirmed that the involved telemetry transmitter and receiver performed to specification.The testing was witnessed by a hospital representative.The customer provided waveform recordings and an alarm list, however the patient¿s historical database was not accessible; without the patient¿s database record, it is not possible to assess the performance of the system¿s detection or classification algorithms.Lacking this data, no conclusion can be drawn.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: michael frey ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635924
• MDR Report Key: 6920000
• MDR Text Key: 90062828
• Report Number: 3010157426-2017-00088
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• 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