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

Model Number 861290

Device Problem Protective Measures Problem (3015)

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

Event Date 08/20/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device displayed an error code.There was no patient involvement.

Manufacturer Narrative

Complaint evaluation: the device was evaluated by the customer with assistance from a philips remote service engineer (rse).An evaluation was completed and the rse was unable to replicate the alleged failure.Customer resolution and conclusion: upon conclusion of the evaluation, the device was found to be fully functional with no replacement parts required, however the rse noted that this malfunction could indicate a faulty therapy cable and advised the call back for further assistance if symptoms return.At this point in time, philips is unable to rule out that a malfunction did not occur.As the issue could not be replicated during evaluation, a definitive cause for the alleged failure could not be determined.The device passed all required testing and was deemed fit for use.The device remains at the customer site.The available information from this report does not support that this malfunction represents a systemic, design, or labeling problem.No further investigation or action is warranted.

Event Description

It was reported to philips that the device failed op check and provided error code 08010070.

• 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: dana tackett ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12451180
• MDR Text Key: 270781816
• Report Number: 3030677-2021-14232
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 09/09/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/20/2021
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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