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

Model Number M3535A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Loss of consciousness (2418)

Event Date 12/03/2021

Event Type  Death  

Event Description

It was reported to philips the device failed on a patient during a code.The shock button was not working.When the user attempted to shock the first time, no shock was delivered.When the user attempted to shock the second time, no shock was delivered.When the user attempted to shock the third time, a shock was delivered.When the user attempted to two more shocks, no shocks were delivered.The patient expired.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported to philips the device failed on a patient during a code.The shock button was not working.The ¿shock ready¿ alert would not go away when the shock button was being clicked.When the user attempted to shock the first time, no shock was delivered.When the user attempted to shock the second time, no shock was delivered.When the user attempted to shock the third time, a shock was delivered.When the user attempted two more shocks, no shocks were delivered.Another defibrillator was used to treat the patient.The patient expired.A philips repair bench technician evaluated the device and found the device had multiple errors.There was a cpr sensor malfunction that required the replacement of the therapy pca and therapy port.There was a therapy switch failure requiring the processor pca and the optical switch to be replaced.A philips clinician reviewed the event file.The first shock attempt occurred at et (elapsed time) 00:38, with the first asystole alarm at et 04:33.The device was placed into sync mode at et 04:38 with device charging to 200j.As the device was in sync mode with no qrs complexes or r wave to apply a sync shock to, the device performed as expected and did not deliver a shock.The second shock attempt occurred at et 05:06 pads off (pads removed from patien).At et 05:06, the ecg source changed to lead ii.There was a dashed line (----) on the display instead of an ecg (ecg data is not being acquired).Without monitoring electrodes placed on patient, there is no signal source for lead ii ecg selected by user.At et 05:43, pads were placed onto patient, ecg lead source selected as pads, and ecg signal re-appears.The device remains in sync mode since selection at et 04 :33.At et 05:50, the device was charging to 200j.As the device was in sync mode with no qrs complexes or r wave to apply a sync shock to, the device performed as expected and did not deliver a shock.The third shock attempt occurred at et 06:06.Sync mode was switched off.At et 06:10, a shock was delivered.The event file also shows et 08:45 asystole alarm and et 09:03 asystole alarm.There were no additional user selections to charge device for shock(s).At et 09:56, aed mode was selected and analysis began.At et 09:56, the device was powered off.No additional charging events were present in the files provided, and therefore no additional shocks were attempted.The repair bench technician replaced the therapy pca, processor pca, therapy switch, and therapy port.The device passed all performance assurance tests and was returned to the customer.As multiple components were installed in the process of repairing the device, a definitive cause for the failure could not be determined.The device performed as expected during the first two attempted shock events, as the device was in sync mode and the patient rhythm was asystole, providing no recognizable qrs complexes to deliver a synchronized shock.The third shock attempt was successful as the device was no longer in sync mode.

Manufacturer Narrative

The final report was already sent.However, it stated that the repair bench replaced the parts when they actually didn't.A gfe dated (b)(6) 2022 from the repair bench clarified that, although they evaluated the device, found which parts needed to be replaced, and were soon to replace the parts, the eol date came around first and they ended up having to send the device back unrepaired.

Event Description

It was reported to philips the device failed on a patient during a code.The shock button was not working.The ¿shock ready¿ alert would not go away when the shock button was being clicked.When the user attempted to shock the first time, no shock was delivered.When the user attempted to shock the second time, no shock was delivered.When the user attempted to shock the third time, a shock was delivered.When the user attempted two more shocks, no shocks were delivered.Another defibrillator was used to treat the patient.The patient expired.A philips repair bench technician evaluated the device and found the device had multiple errors.There was a cpr sensor malfunction that was traced to the therapy pca and therapy port.There was a therapy switch failure traced to the processor pca and the optical switch.A philips clinician reviewed the event file.The first shock attempt occurred at et (elapsed time) 00:38, with the first asystole alarm at et 04:33.The device was placed into sync mode at et 04:38 with device charging to 200j.As the device was in sync mode with no qrs complexes or r wave to apply a sync shock to, the device performed as expected and did not deliver a shock.The second shock attempt occurred at et 05:06 pads off (pads removed from patient).At et 05:06, the ecg source changed to lead ii.There was a dashed line (----) on the display instead of an ecg (ecg data is not being acquired).Without monitoring electrodes placed on patient, there is no signal source for lead ii ecg selected by user.At et 05:43, pads were placed onto patient, ecg lead source selected as pads, and ecg signal re-appears.The device remains in sync mode since selection at et 04 :33.At et 05:50, the device was charging to 200j.As the device was in sync mode with no qrs complexes or r wave to apply a sync shock to, the device performed as expected and did not deliver a shock.The third shock attempt occurred at et 06:06.Sync mode was switched off.At et 06:10, a shock was delivered.The event file also shows et 08:45 asystole alarm and et 09:03 asystole alarm.There were no additional user selections to charge device for shock(s).At et 09:56, aed mode was selected and analysis began.At et 09:56, the device was powered off.No additional charging events were present in the files provided, and therefore no additional shocks were attempted.The customer was informed that service could no longer be completed on the unit as the device had reached end of life (eol).The heartstart mrx device and all associated service/support was discontinued on (b)(6) 2022.The repair bench technician was not able to replace the therapy pca, processor pca, therapy switch, and therapy port as the device had reached end of life (eol).As multiple components were identified during evaluation of the device, a definitive cause for the failure could not be determined.The device performed as expected during the first two attempted shock events, as the device was in sync mode and the patient rhythm was asystole, providing no recognizable qrs complexes to deliver a synchronized shock.The third shock attempt was successful as the device was no longer in sync mode.The customer was aware of the end of life terms and the device was returned back to the customer unrepaired.No further investigation or action is warranted.

• 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: jacqueline nishino ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 13061985
• MDR Text Key: 282635616
• Report Number: 3030677-2021-16528
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• 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,Followup

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: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 12/03/2021; 12/03/2021
• Supplement Dates FDA Received: 02/15/2022; 03/04/2022
• 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
• Patient Outcome(s): Death