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

Model Number M3535A

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Myocardial Infarction (1969)

Event Date 04/07/2021

Event Type  Death  

Event Description

It was reported to philips that the patient arrived to the er with ems during cardiac arrest (t3).It was reported that the 1st rhythm check with philips monitor/defib reading rhythm via pads showed ventricular tachycardia.It was reported that the shock delivered successfully.It was reported that during the 2nd rhythm check, the pads were charged to 200j, however a message appeared saying 'pads disconnected, connect cables' even though nothing had changed between rhythm checks.It was reported that new pads were applied but same error message appeared.It was reported that the device was unable to defibrillate the patient despite a shockable rhythm.It was reported that cpr resumed until new monitor/defib obtained, that a successful shock delivered with new monitor but delayed defibrillation.The patient expired.

Manufacturer Narrative

The fse evaluated the device on site.It was determined that this was a malfunction of the therapy cable, which was replaced, and the device was returned to full functionality.The device remains at the customer site and no further evaluation is warranted at this time.

• 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: daniel derochers ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15486948
• MDR Text Key: 300627728
• Report Number: 3030677-2022-04453
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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

• Is this an Adverse Event Report?: Yes
• 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?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 05/15/2023
• 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
• Patient Outcome(s): Death