MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECIEVER HOUSING; TELEMETRY HOUSING

Model Number 90479

Device Problems Overheating of Device (1437); Loss of Power (1475); Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

Patient monitoring continued by moving the telemetry modules to other available slots.The seven year old device was sent to spacelabs for further analysis.The reported problem was verified.The power supply and the battery assembly were replaced.The repaired unit passed all functional tests and was restored to service.This report is complete and this particular issue is considered closed.

Event Description

Spacelabs received a reported that on (b)(6) 2016, the telemetry module housing became overheated, powered off, and would not power back on.No injury was reported as a result of this event.

• Brand Name: SPACELABS TELEMETRY RECIEVER HOUSING
• Type of Device: TELEMETRY HOUSING
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: daniel herrera ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635631
• MDR Report Key: 6074480
• MDR Text Key: 59226662
• Report Number: 3010157426-2016-00175
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 90479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/02/2016
• 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