MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS TELEMON; DETECTOR AND ALARM, ARRHYTHMIA

Model Number M2636C

Device Problem Break (1069)

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

Event Date 08/06/2016

Event Type  malfunction  

Event Description

The telemetry box pins were broken where it connects to the telemon.

• Brand Name: TELEMON
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• MDR Report Key: 6103082
• MDR Text Key: 59936113
• Report Number: 6103082
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M2636C
• Other Device ID Number: US51406881
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1