MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Ventricular Fibrillation (2130); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

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 the device did not deliver required shock during ventricular fibrillation.The device was reported to be in use on a patient, causing a delay in life saving therapy 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 that the device did not deliver required shock during ventricular fibrillation.The device was reported to be in use on a patient, causing a delay in life saving therapy 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) evaluated the device and was unable to duplicate the issue.

Manufacturer Narrative

A final report will be submitted upon completion of the investigation.

Event Description

It was reported to philips that the device did not deliver required shock during ventricular fibrillation.The device was reported to be in use on a patient, causing a delay in life saving therapy 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) evaluated the device and was unable to duplicate the issue.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported to philips that the device did not deliver required shock during ventricular fibrillation.The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.No additional information regarding the patient or procedure was received from the customer.A philips field service engineer (fse) evaluated the device and was unable to duplicate the issue.No ecg monitoring strips or case event files were provided to philips 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 NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: jessica ruuth ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12124798
• MDR Text Key: 260214633
• Report Number: 3030677-2021-12724
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K021453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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
• Device Catalogue Number: M4735A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/21/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 09/03/2021; 09/03/2021; 11/24/2021
• Supplement Dates FDA Received: 09/30/2021; 11/01/2021; 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening; Required Intervention