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

Model Number M3535A

Device Problem Noise, Audible (3273)

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

Event Date 04/10/2024

Event Type  malfunction  

Event Description

It was reported to philips that the heartstart mrx defibrillator exhibited noise in the power supply.Patient involvement is unknown at this time, however, no adverse patient impact or injury was reported by the customer.Additional information has been requested.

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.

Manufacturer Narrative

This report is based on information provided by philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on a heartstart mrx device indicating that the device had a noise in the power supply.The customer was informed that service could no longer be completed on the unit as the device had reached end of life (eol).The heartstart mrx device and all associated service/support was discontinued on 03-feb-2022.As troubleshooting was not completed for the device, the reported issue could not be verified, and a cause could not be established.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The customer was made aware of the end of life terms and the device remains at the customer site.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 19201232
• MDR Text Key: 341258333
• Report Number: 3030677-2024-01551
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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

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: 04/10/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2006
• 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