MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2020

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 failed to deliver a shock to a patient on the first attempt, then delivered the shock on the second attempt.Additional details have been requested.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.

Event Description

It was reported to philips the device failed to deliver a shock to a patient on the first attempt, then delivered the shock on the second attempt.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.The customer contacted the philips response center.The response center provided information regarding end of service / end of life.According to service bulletin sb86100166d, the m4735a heart/start xl portable defibrillator/monitor was discontinued on 31-december -2013.All options associated with this defibrillator were discontinued as of 31-december-2013.The end of support date for the device is 31-december -2018.The customer was aware of the end of life terms and the device remains at the customer site.

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.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10685623
• MDR Text Key: 211539914
• Report Number: 1218950-2020-06131
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

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: M4735A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening