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

Model Number M3535A

Device Problems Device Alarm System (1012); Computer Software Problem (1112)

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

Event Date 12/15/2022

Event Type  malfunction  

Event Description

It was reported to philips that the device displayed error codes in the status log.There was no reported patient impact or injury.

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

Philips received a complaint on the heartstart mrx indicating that there was an error message.There was reportedly no patient involvement.Remote support from the customer care solution center was received, during which a quote was provided for diagnostic service.It was determined that this was a malfunction of the processor pca for which the rse informed the customer that a replacement is necessary.The rse recommended replacing the processor pca to resolve the issue.The device remains at the customer site.No further action is warranted at this time.H3 other text : remote support provided.

• 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: sara carlson ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16241223
• MDR Text Key: 308099991
• Report Number: 3030677-2023-00338
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/15/2022
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2013
• 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