MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS; TRX TELEMETRY PACK

Model Number 4841A

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 03/12/2018

Event Type  Injury  

Event Description

Device reported as hot.Investigation revealed an insulator separating battery positive and negative failed.Subsequent evaluation of like devices showed several device failures of the same nature.Manufacturer stated this is a known problem.Remove from service on failure.

• Brand Name: PHILIPS
• Type of Device: TRX TELEMETRY PACK
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS
• MDR Report Key: 7564997
• MDR Text Key: 110163242
• Report Number: MW5077605
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4841A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention