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

Model Number M3535A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Electric Shock (2554)

Event Date 03/26/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

A customer reported that a shock was delivered then the ecg leads jiggled during an event in which a patient died.Additional details have been requested.

Event Description

A customer reported that a shock was delivered then the ecg leads jiggled during an event in which a patient died.The customer initially reported that, after the defibrillator delivered a shock, the leads ¿jiggled¿.A nurse from the hospital provided additional information, reporting that a patient coded, was connected to the defibrillator via pads, and that 8 shocks were delivered via pads.The patient was then significantly diaphoretic requiring the user to change the defib pads several times.During this timeframe, the device did not deliver a shock.No ecg waveforms from the event were provided to philips for review and the brand of defib pads was not reported.It was not reported to philips what the users did after the period where they had to change the defib pads multiple times.A philips field service engineer (fse) evaluated the device and was unable to duplicate the issue.The device passed all testing.The troubleshooting chapter of the heartstart mrx instructions for use (ifu - publication 453564307761), provides information on the importance of skin prep, dry skin and replacing defib pads as needed to obtain an ecg waveform.The customer performed the correct troubleshooting steps when they changed the defib pads due to the patient's significant diaphoresis.The symptoms as reported by the customer and the available information is consistent with initial adequate pads to patient contact that allowed 8 shocks to be delivered, followed by a period of significant diaphoresis requiring a change in the defib pad multiple times and intermittency of the ecg waveform, and not a malfunction of the device.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: laura scanlan ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9911688
• MDR Text Key: 185984629
• Report Number: 1218950-2020-02091
• Device Sequence Number: 1
• Product Code: MKJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2012
• 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