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

Model Number M4735A

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

Patient Problem Burn, Thermal (2530)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that a patient experienced a "burn" during a cardioversion procedure.A description and photographs of the reported burn, energy levels and number of shocks delivered, and whether treatment was required for this patient have been requested, but not yet received.Redness of the skin is an expected observation with the delivery of energy via pads.As we do not have any additional information we are considering this to be a serious injury.

Event Description

It was reported to philips that while using the heartstart xl monitor / defibrillator, a patient experienced a "burn" during a cardioversion procedure.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.This complaint has been updated from a serious injury to a non adverse event.

Manufacturer Narrative

(b)(4) is being considered a duplicate of (b)(4) as the serial numbers are the same and the event was reported through two different sources.Refer to (b)(4) and mdr 1218950-2018-09608 for details on the investigation and conclusion of this case.This mdr (above) coded identical to mdr 1218950-2018-09608.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: bethany glynn ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8240331
• MDR Text Key: 132819775
• Report Number: 1218950-2019-00355
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2002
• 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): Other