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

Model Number M3535A

Device Problem No Display/Image (1183)

Patient Problem Injury (2348)

Event Date 10/04/2020

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is completed.

Event Description

It was reported to philips the device had provided a first shock to a patient and, when the user was recharging to get ready for next shock, the defibrillator screen went black.Another device was used to treat the patient.The device was reported to be in use on a patient, causing a delay in life threatening therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.

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, while treating a patient with ventricular tachycardia, the device had provided a first shock to a patient and, when the user was recharging to get ready for next shock, the defibrillator screen went black.Another device was used to treat the patient.The device was reported to be in use on a patient, causing a delay in life saving therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.No ecg monitoring strips or case event files were provided to philips for review.A philips repair bench technician evaluated the device.The technician could not reproduce the reported issue, however, the evaluation showed a failure of the battery and the capacitor which were traced to the reported issue.The repair bench technician replaced the capacitor and recommended to the customer to replace the battery.The device passed all performance assurance tests and was returned to the customer.Multiple parts needed replacement by the repair bench; we are unable to determine the cause of the reported symptom as more than one part was replaced.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10727478
• MDR Text Key: 212763626
• Report Number: 1218950-2020-06384
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 41 YR