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

Model Number	M3536M
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the device experienced a co2 calibration failure.The customer requested assistance from a philips remote service engineer (rse).The customer explained that their unit was not showing a co2 value and subsequently failing operational testing.Based on the noted issue, the rse advised the customer to swap out the co2 cable in an attempt to troubleshoot the issue.Should the issue remain, the customer was then instructed to replace the etco2 module.Based on the conclusion of the investigation, it was determined that this was a malfunction of the co2 cable.The customer followed the instruction provided by the rse and verified that swapping out the co2 cable resolved the reported failure.The device remains at the customer site.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: jessica ruuth ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12771830
• Report Number: 3030677-2021-15443
• Device Sequence Number: 4254260
• Product Code: MKJ
• UDI-Device Identifier: 00884838006676
• UDI-Public: 00884838006676
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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