MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILLATOR

Model Number M3535A

Device Problem Complete Loss of Power (4015)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

It was reported the device does not allow functional verification as it immediately gives the battery faulty message and switches off, the device was reported to be in use, however, no direct adverse event to the patient or user was reported.

Manufacturer Narrative

This report is based on information provided by philips remote service engineer (rse) and field service engineer (fse) personnel and has been investigated by the philips complaint handling team.Philips received a complaint about the heartstart mrx indicating a low battery alarm.The device was not in clinical use at the time the issue was discovered.The complaint investigation revealed that the defibrillator's low battery alarm was due to a faulty battery in an old device that is no longer supported.Since the device is out of support and spare parts are no longer available, an out-of-support letter was sent.Based on available information and testing, the cause of the reported issue with the defibrillator's low battery alarm was attributed to a faulty battery in an outdated device that lacked support and spare parts availability.Since the device is out of support and spare parts are no longer available, an out-of-support letter was sent.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : device is out of support.

Event Description

It was reported the device does not allow functional verification as it immediately gives the battery faulty message and switches off, philips received a complaint about the heartstart mrx indicating a low battery alarm.The device was not in clinical use at the time the issue was discovered.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 18633842
• MDR Text Key: 334611905
• Report Number: 3030677-2024-00426
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 03/07/2024
• 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