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

Model Number M3536A

Device Problem Device Remains Activated (1525)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device did not turn off completely, some functions remained lit.There was no patient involvement.

Event Description

It was reported to philips that the device did not turn off completely, some functions remained lit.An authorized field service engineer (fse) was dispatched to the customer site and the reported issue could not be confirmed, the unit shutdown as normal.The device was tested and the fse was unable to reproduce the customer's reported problem.Upon conclusion of the evaluation, the fse was unable to duplicate the reported problem.Operational testing was conducted and the device passed all required testing with no replacement parts required.As the reported problem was unable to be reproduced, the cause could not be determined.Philips is unable to rule out that a malfunction did not occur.The device remains at the customer site and no further evaluation 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: elizabeth proctor ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12882703
• MDR Text Key: 281328606
• Report Number: 3030677-2021-15970
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 11/29/2021
• 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?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2004
• 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