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

Model Number M4735A

Device Problem Device Alarm System (1012)

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

Event Date 08/10/2022

Event Type  malfunction  

Event Description

It was reported that the device had an alarm at setup.There was no patient involvement.The customer was informed that the device is past end of support, therefore, it was not evaluated.According to service bulletin sb86100166d, the m4735a heart/start xl portable defibrillator/monitor was discontinued on 31- december -2013.All options associated with this defibrillator were discontinued as of 31-december-2013.The end of support date for the device is 31-december -2018.The customer was aware of the end of life terms and the device remains at the customer site.

• 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: daniel derochers ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15301043
• MDR Text Key: 304599123
• Report Number: 3030677-2022-04116
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4735A
• Device Catalogue Number: M4735A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: No
• 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