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

Model Number M3536A

Device Problem Failure to Discharge (1169)

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

Event Date 01/10/2022

Event Type  malfunction  

Event Description

It was reported to philips that the shock delivery buttons are not functioning.There was no patient involvement.The customer worked with the technical support representative.The device needs external paddles.Upon conclusion of the evaluation, it was determined that this was a malfunction of the external paddles, the replacement for which was ordered to customer.The customer to install paddles.The device remains at the customer site and no further evaluation is warranted 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: daniel derochers ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 13392106
• MDR Text Key: 284682103
• Report Number: 3030677-2022-00578
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2015
• 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