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

Model Number 90479

Device Problem Failure to Power Up (1476)

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

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

The product was received at spacelabs¿ equipment service center for repair.The reported problem was verified.Battery assembly (b)(4) and pcba (b)(4) power supply were not functioning; therefore the parts were replaced.The repaired unit passed all functional tests and was returned to the customer.Lack of an ecg trace was the warning sign that the customer noticed and that prompted the action of removing the product from use.This report is complete and this particular issue is considered closed.Spacelabs monitors its complaints for similar product issues to determine need for additional investigation.

Event Description

Spacelabs received telemetry module housing model 90479 for service repair with customer complaint of no power.The customer removed the product from service on (b)(6) 2015.No injury was reported.

• 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: john zeng ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635915
• MDR Report Key: 5320680
• MDR Text Key: 34922423
• Report Number: 3010157426-2015-00185
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/22/2015

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: 11/23/2015
• Initial Date FDA Received: 12/22/2015
• 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