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

Model Number	M3536M
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the co2 module was not working.There was no patient involvement.
Additional Manufacturer Narrative
H3 other text : customer refused quote for service.
Event or Problem Description
It was reported to philips that the co2 module was not working.The customer requested assistance from a philips representative.The customer explained that the co2 module for their device was faulty and needed to be replaced.The service order was initiated as a means for the customer to obtain a quote for the cost of repair at the bench and an evaluation of the device was not requested at this time.Based on the available information, it was determined that this was a malfunction of the co2 module.The customer was provided a quote for the cost of the repair and will create a new service order if they wish to resolve the reported issue.The device remains at the customer site and no further assistance was required or requested.

• Brand Name: HEARTSTART MRX AIRWORTHY
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 12701067
• Report Number: 3030677-2021-15229
• Device Sequence Number: 3991247
• Product Code: MKJ
• UDI-Device Identifier: 00884838006676
• UDI-Public: 00884838006676
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,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
• Operator of Device: Health Professional
• Device Model Number: M3536M
• Device Catalogue Number: M3536M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1