MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX AIRWORTHY; DEFIBRILLATOR

Model Number	M3536M
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the device experienced a charge button failure, and showed an error message that service is required.There was no patient involvement.The customer was provided remote support from an authorized remote service engineer (rse).Error messaging suggest a shock may not be able to be performed.The rse was unable to replicate the reported failure through remote service.Current operation checks passed with no errors.Status logs point to the failed op check being an isolated incident (only one occurrence).Since the users routinely perform this operational check on several mrx units in the am everyday, its possible that they ran this particular check and walked away without pressing the charge button.The device can finish its operational check without the press of the button but it reports this as a major failure and yields the "device needs service" message in normal mode.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.Competed a charge button test and passed a current operational check.Error message went away and the device was returned to service.There is no indication of a systemic problem.No further investigation or action is warranted.
Event or Problem Description
It was reported to philips that the device experienced a charge button failure, and showed an error message that service is required.There was no patient involvement.The customer was provided remote support from an authorized remote service engineer (rse).Error messaging suggest a shock may not be able to be performed.The rse was unable to replicate the reported failure through remote service.Current operation checks passed with no errors.Status logs point to the failed op check being an isolated incident (only one occurrence).Since the users routinely perform this operational check on several mrx units in the am everyday, its possible that they ran this particular check and walked away without pressing the charge button.The device can finish its operational check without the press of the button but it reports this as a major failure and yields the "device needs service" message in normal mode.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.Competed a charge button test and passed a current operational check.Error message went away and the device was returned to service.There is no indication of a systemic problem.No further investigation or action is warranted.

• Brand Name: HEARTSTART MRX AIRWORTHY
• Common Device Name: 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: 13573510
• Report Number: 3030677-2022-01114
• Device Sequence Number: 4533438
• Product Code: MKJ
• UDI-Device Identifier: 00884838006676
• UDI-Public: 00884838006676
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K031187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: M3536M
• Device Catalogue Number: M3536M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown