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

Model Number M3535A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.Patient information has been requested.

Event Description

It was reported to philips that no shock was released from the device during cardioversion on (b)(6) 2020 (addressed in (b)(4).The customer stated this issue occurred twice during the previous week (exact dates are unknown).This report addressed the first issue which occurred during the previous week (b)(4).The second issue from the previous week is addressed in (b)(4).Additional details have been requested.The device was reported to be in use on a patient, causing a delay in possibly 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

This complaint is a duplicate of (b)(4) previously reported on mdr number 1218950-2020-06565.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

This complaint is a duplicate of (b)(4) previously reported on mdr number 1218950-2020-06565.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10764360
• MDR Text Key: 214086847
• Report Number: 1218950-2020-06566
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: (01)00884838000018
• Combination Product (y/n): N
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1