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	07/02/2024
Type of Reportable Event	Malfunction
Additional 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.Reporter phone #: (b)(6).
Event or Problem Description
It was reported to philips that the heartstart mrx defibrillator exhibited co2 calibration problems.There was no reported patient involvement.
Additional Manufacturer Narrative
This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart mrx device indicating that the co2 calibration expired.The fse evaluated the device at the customer¿s location and determined that it expired the co2 calibration.The engineer performed the co2 calibration, restored the device to good condition, and handed it over to the customer in working condition.The device remains at the customer site, and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a co2 calibration expiration.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The device underwent co2 calibration to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received, the complaint file will be reopened.
Additional Manufacturer Narrative
This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart mrx device indicating that the co2 calibration expired.The fse evaluated the device at the customer¿s location and determined that it expired the co2 calibration.The engineer performed the co2 calibration, restored the device to good condition, and handed it over to the customer in working condition.The device remains at the customer site, and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a co2 calibration expiration.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The device underwent co2 calibration to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received, the complaint file will be reopened.

• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 19831644
• Report Number: 3030677-2024-02604
• Device Sequence Number: 7504357
• Product Code: MKJ
• UDI-Device Identifier: 00884838006676
• UDI-Public: (01)00884838006676(21)US00500248
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 09/30/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 10/07/2024; 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2010
• 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