MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT WORN DEVICE; TELEMETRY

Model Number M4841A

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reports no alarms are heard if the battery is low.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

H10: the cause of the issue is unknown due to unauthorized modifications being made on the device.The device remains at the customer site.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.H3 other text : the philips remote service engineer (rse) assessed the situation and found the m4841 devices were repaired by a third party.

• Brand Name: PATIENT WORN DEVICE
• Type of Device: TELEMETRY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10535576
• MDR Text Key: 207904091
• Report Number: 1218950-2020-05409
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K040357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4841A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1