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

Model Number M4735A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A customer reported that the device would not shock.This event will be reported as a serious injury because the device would not shock while in use on a patient.

Event Description

It was reported to philips that the device failed to shock while in use on a patient.The device was report to be in use on a patient, causing a delay in therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.A philips field service engineer (fse) did not evaluate the device.The customer was informed that the device is past the end of service date and no more parts are available.According to service bulletin sb86100166d, the m4735a heart/start xl portable defibrillator/monitor was discontinued on (b)(6)2013.All options associated with this defibrillator were discontinued as of (b)(6)2013.The end of support date for the device is (b)(6)2018.The customer was aware of the end of life (eol) terms and the device remains at the customer site.The information gathered for this report does not indicate a systemic, design, or labeling problem.No further investigation or action is warranted.

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.H3 other text : a philips field service engineer (fse) did not evaluate the device.The customer was informed that the device is past the end of service date and no more parts are available.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9537756
• MDR Text Key: 173279612
• Report Number: 1218950-2020-00004
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000001
• UDI-Public: (01)00884838000001
• Combination Product (y/n): N
• PMA/PMN Number: K001725
• 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: 12/19/2019

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: M4735A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1