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

Model Number M3535A

Device Problems Fitting Problem (2183); Material Integrity Problem (2978)

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

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported to philips that while the unit was at bench repair, it was found that the paddle cable had a cut on it.The customer requested that the device be returned for bench repair.The device was received by the bench repair service on 16nov2021.Upon evaluation of the device, the reported issue was confirmed and the cause was traced to a faulty paddle cable.Based on the conclusion of the investigation, it was determined that this was a malfunction of the paddle cable.The paddle cable was replaced and the device passed all testing.The device remains at the customer site.There is no indication of a systemic problem.No further investigation or action is warranted.Was the device being used on a patient at the time of the event, including for the purposes of diagnosis? no.Was there any adverse event to the patient or user.If yes, describe? no, the event did not occur during clinical use.If there was an adverse event, did the device cause or contribute to the adverse event, and how? no, there was reportedly no adverse event.

• 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: allison prater ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 14572385
• MDR Text Key: 293143043
• Report Number: 3030677-2022-02592
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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