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

Model Number M3536M

Device Problem Failure to Calibrate (2440)

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

Event Date 07/19/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device failed to perform co2 calibration.There was no patient involvement.

Event Description

It was reported to philips that the device failed to perform co2 calibration.There was no patient involvement.

• Brand Name: HEARTSTART MRX AIRWORTHY
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 12311000
• MDR Text Key: 266164217
• Report Number: 3030677-2021-13582
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006676
• UDI-Public: 00884838006676
• Combination Product (y/n): N
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536M
• Device Catalogue Number: M3536M
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/19/2021
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1