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

Model Number M4841A

Device Problem Failure to Analyze Signal (1539)

Patient Problems Cardiac Arrest (1762); Death (1802); Hypoxia (1918)

Event Date 11/04/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that the telemetry device had weak/ loss of ecg signal.The patient was hypoxic, coded, and then expired.

Manufacturer Narrative

An analysis of the reported incident was unable to be conducted by a philips product support engineer (¿pse¿) as the device logs requested were either empty and/or overwritten for the timeframe of the event on (b)(6) 2019.Additionally, pse was informed that the m4841a patient worn device was repaired by a 3rd party service provider called avante health solutions and not by philips healthcare bench repair.The 3rd party testing results of the m4841a patient worn device is an indication that the weak/loss of ecg signal was related to the device being physically damaged and the ecg block being damaged/corroded.

• Brand Name: PATIENT WORN DEVICE
• Type of Device: TELEMETRY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9418892
• MDR Text Key: 169405244
• Report Number: 1218950-2019-09220
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040357
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4841A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2013
• 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
• Patient Outcome(s): Death