MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC TELE MX40, 2.4 GHZ, ECG ONLY, EXCHANGE

Model Number 865351

Device Problems No Device Output (1435); Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2022

Event Type  Death  

Event Description

The customer reported that the device displayed a weak signal resulting in a death.

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Reporter information: (b)(6).

Event Description

The customer reported that the device displayed a weak signal resulting in a death.The customer reported that the device alarm for "no data tele" did alarm and was acknowledged by users.

Manufacturer Narrative

The philips remote service engineer (rse) indicated the piic did alarm with 'no data tele' and this was acknowledged by the staff; however, it remains unclear the reason for the disconnection between piic and mx40.The alarm for 'no data tele' did alarm and was acknowledged by users.The device was confirmed to be operating per specifications and no failure was identified.

• Brand Name: TELE MX40, 2.4 GHZ, ECG ONLY, EXCHANGE
• Type of Device: TELE MX40, 2.4 GHZ, ECG ONLY, EXCHANGE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16194230
• MDR Text Key: 307574474
• Report Number: 1218950-2023-00031
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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: 865351
• Device Catalogue Number: 865351
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: No
• 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