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

Model Number 861290

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

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.Reporting institution phone #/ reporter phone #: (b)(6).

Event Description

It was reported to philips that the heartstart xl+ exhibited a ecg malfunction.Patient involvement is unknown at this time, however, no adverse patient impact or injury was reported by the customer.Additional information has been requested.

Manufacturer Narrative

This report is based on information provided by a philips call center personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl+ defibrillator indicating that there is an electrocardiogram (ecg) malfunction.Available details indicate that a quote for onsite labor and service was provided, but the customer did not accept the quote and the quote expired.A good faith effort was made to obtain additional information associated with this complaint evaluation, but there is no additional information available.We are unable to confirm the final disposition of the device as there is no additional information available.No services or repairs were performed.No further investigation is possible.As troubleshooting was not completed for the device, the reported issue could not be verified and a cause could not be established.The reported problem was not confirmed.The customer was provided a quote to resolve the issue, but the customer did not accept the quote and the quote expired.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : the customer did not accept the quote for service.

• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 19031830
• MDR Text Key: 339234120
• Report Number: 3030677-2024-01217
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 03/14/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2015
• 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