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

Model Number M4735A

Device Problem Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

Event Type  Injury  

Event Description

This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl the device displayed a low battery message and then turned off.There was reportedly patient involvement but no patient injury.The fse evaluated the device on site.It was determined that this was a malfunction of the battery.The battery is not available since the device is end-of-support since 31dec2028.The device remains at the customer site and no further evaluation is warranted at this time.Multiple requests have been made to ascertain if the device event reported (turned off during use) occurred during patient use and whether this result in a failure to shock situation.We have not received confirmation of the information and can therefore not assess if life-threatening delay of care occurred during patient use.Given this consideration the information does not indicate that an adverse event occurred.However, if additional information is received which indicates otherwise, please request a clinical reassessment.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the battery.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The battery is not available since the device is end-of life.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

Correction: this report has been updated from product problem to serious injury this report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl the device displayed a low battery message and then turned off.There was reportedly patient involvement but no patient injury.Multiple requests for confirmation of a failure to shock event were not successful.Although no harm was reported by the user, the delay in treatment caused by the reported device failure event will be an adverse event out of an abundance of caution because live-saving therapy/treatment has been interrupted and or delayed and likely led to a deterioration in the state of the health of the patient.

Manufacturer Narrative

Correction: this report has been updated from product problem to serious injury.

• 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: laura scanlan ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16809602
• MDR Text Key: 313948982
• Report Number: 3030677-2023-01722
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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

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
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 05/01/2023
• 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