MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR

Model Number 861290

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/25/2021

Event Type  malfunction  

Event Description

It was reported that the device's ecg failed.There was reportedly no patient involvement.

Event Description

It was reported that the device ecg failed.There was reportedly no patient involvement.The customer evaluated the device and received remote support from the customer care solution center, during which a replacement of ecg lead wire was recommended.Upon conclusion of the evaluation, it was determined that this was a malfunction of the ecg lead wire, the replacement for which was recommended.The device remains at the customer site and no further evaluation is warranted at this time.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• 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: lois price ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12475704
• MDR Text Key: 271516995
• Report Number: 3030677-2021-14313
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 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?: No
• 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?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 04/21/2022
• 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