MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR

Model Number M3535A

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 12/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips that the heartstart mrx monitor / defibrillator shocked a patient when it should not have, due to no charge or shock button being pressed.Philips is considering this event to be a serious injury because the patient was unintentionally shocked.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

It was reported to philips that the heartstart mrx monitor / defibrillator shocked a patient when it should not have, due to no charge or shock button being pressed.Philips is considering this event to be a serious injury because the patient was unintentionally shocked.A philips field service engineer (fse) evaluated the device and was unable to duplicate the symptom.This nurse reported that a 56 years old male patient weighing 121 kilograms (kg) was admitted to a hospital on an unknown date with the admitting diagnosis not reported.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on (b)(6) 2019, the patient experienced a heart rhythm with details not reported, hospital staff to connect the patient to the heartstart mrx, the patient was no longer experiencing the rhythm with details not reported, but the mrx delivered a shock to the patient without the charge or shock button being pressed.It was reported that the patient felt the shock but did not incur any injuries as a result.No relevant laboratory data was reported.Review of the provided ecg rhythm strips and case event file showed that the device was powered on into manual mode with defibrillator pads placed at 12:45:17 am on (b)(6) 2019.At 00:06 elapsed time (et) there were multiple occurrences of artifact with no discernable underlying heart rhythm, the device was charged with 150 joules (j) of energy, and shock 1 at 153 j was delivered to the patient at 00:22 et.At 00:25 et, the heart rhythm was consistent with a narrow qrs complex and the device was powered off at 02:52 et.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.There was no malfunction of the device.The device was behaving as intended when it was manually charged with 150 j of energy and the n delivered that energy when the shock button was pressed.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9490717
• MDR Text Key: 171892392
• Report Number: 1218950-2019-09548
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 121