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

Model Number M3535A

Device Problems Delayed Charge Time (2586); Charging Problem (2892)

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

Event Date 03/23/2024

Event Type  malfunction  

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.

Event Description

It was reported to philips that the heartstart mrx charging time is longer than before.There was no reported patient involvement.

Manufacturer Narrative

This report is based on information provided by philips authorized service provider (asp) personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart mrx indicating the charging time had increased.The asp evaluated the device and found no problems.There was no device malfunction.No further actions are required.Based on the information available and the testing conducted, the device had no problems.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 device was not malfunctioning.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: 19042924
• MDR Text Key: 339391273
• Report Number: 3030677-2024-01254
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/23/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2014
• 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