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

Model Number 90479

Device Problem Power Problem (3010)

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

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation into this event and will file a supplemental report once the investigation is complete.

Event Description

Spacelabs received a report on (b)(6) 2016 the telemetry module housing had power supply issue during patient use.No injury was reported as a result of this event.

Manufacturer Narrative

The spacelabs field service engineer was dispatched to the customer site for further analysis.The reported problem was verified.The power supply and battery 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.

• 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: 5938227
• MDR Text Key: 54655672
• Report Number: 3010157426-2016-00098
• 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,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

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: Health Professional
• Device Model Number: 90479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2016
• 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