MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; ALS DEFIBRILLATOR MONITOR

Model Number 861290

Device Problems Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that the device displays error messages: 9:2 and 10:2 (comm failure).There was no patient involvement.

Event Description

It was reported to philips that the device displays error messages: 9:2 and 10:2 (comm failure).There was no patient involvement.

Manufacturer Narrative

Report originally submitted with cfn# 1218950, the correct cfn# is 3030677.

Event Description

It was reported to philips that the device displays low battery and error code messages.There was no patient involvement.A philips repair bench technician evaluated the device and confirmed the issue.The issue was traced to the processor pca and battery pca.The repair bench technician replaced the processor pca and battery pca.The device passed all performance assurance tests and was returned to the customer.As multiple components were installed in the process of repairing the device, a definitive cause for the failure could not be determined.One therapy pca was returned for failure analysis.The therapy pca returned "low battery error".This was verified.Unable to determine root cause.

Manufacturer Narrative

Report originally submitted with cfn #1218950; the correct cfn # is 3030677.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: ALS DEFIBRILLATOR MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell-everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 2100 bothell-everett highway; bothell WA 98021
• Manufacturer Contact: daniel derochers ; 22100 bothell everett hwy; bothell, WA 98021 ; 9786871501
• MDR Report Key: 11216157
• MDR Text Key: 229357165
• Report Number: 1218950-2021-00468
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: (01)00884838023680
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• 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