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

Model Number M4735A

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

It was reported to philips that the heartstart xl defibrillator did not shock when needed.Another defibrillator was used to provide therapy to the patient.The patient was taken to intensive care and intubated.

Manufacturer Narrative

A philips field service engineer evaluated the device and was unable to duplicate the failure.There were no electronic event files or ecg monitoring waveforms available for review.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.Philips was not able to confirm the reported malfunction.Because the problem could not be recreated, the cause cannot be determined.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6040519
• MDR Text Key: 57851942
• Report Number: 1218950-2016-06586
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• 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: 10/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2007
• 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): Required Intervention