MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problems Battery Problem (2885); Charging Problem (2892)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

It was reported to philips that the device needs a new battery.There was no patient involvement.

Manufacturer Narrative

Available details indicate that the battery cannot be charged.Specifically, the device only works on the alternative current (ac) power.When the device is connected and powered by the ac power, the battery is able to fully charge and the device will function with no issues.When the device is not connected to the ac power, the device immediately shuts down and will not power on.The customer has been provided diagnostic analysis and a quote for repairs and services.The customer has not accepted the quote and the case closed.The device is not expected for return and remains at the customer site.Based on the information available and the testing conducted, the cause of the reported problem was an apparent component failure.The root cause of the reported problem could not be confirmed because the device was not returned for additional investigation.The reported problem was confirmed.The customer was provided the engineer's analysis findings and was provided a quote for repair and services.The customer has not accepted the quote and the case closed.The investigation concludes that no further action is required at this time.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• 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: 18326250
• MDR Text Key: 330496068
• Report Number: 3030677-2023-04964
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• 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
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• 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