MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; XL+ DEFIBRILLATOR

Model Number 861290

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Ventricular Tachycardia (2132)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips that after charging the device to 200j for a patient in ventricular tachycardia (vt), the device gave a message indicating the shock was cancelled.The users switched to a different defibrillator and the same thing happened.This complaint documents the first defibrillator used.(b)(4) documents the first defibrillator used.The involved patient was reported to be in ventricular tachycardia (vt).The outcome of the patient is not yet known.This is being documented as a serious injury as the patient was in vt.Philips has requested additional information.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.

Event Description

It was reported to philips that after charging the device to 200j for a patient in ventricular tachycardia (vt), the device gave a message indicating the shock was cancelled.The users switched to a different defibrillator and the same thing happened.This complaint documents the first defibrillator used.Pr# 9043316 documents the second defibrillator used.The involved patient was reported to be in ventricular tachycardia (vt).The outcome of the patient is not known.This is being documented as a serious injury as the patient was in vt.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.

Manufacturer Narrative

Pr 9043315 is being considered a duplicate of (b)(4).Please refer to (b)(4) and mdr 1218950-2019-01388 for details on the investigation and conclusion of this case.This mdr (above) coded identical to mdr 1218950-2019-01388.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: XL+ 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: 8425450
• MDR Text Key: 138955749
• Report Number: 1218950-2019-02072
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K110825
• 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: 02/15/2019

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: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 02/15/2019; 02/15/2019
• Supplement Dates FDA Received: 06/26/2019; 08/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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