MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILLATOR

Model Number M3535A

Device Problem Charging Problem (2892)

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

Event Date 03/08/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device experienced a charge button failure.There was no patient involvement.

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.

Event Description

It was reported to philips that the device experienced a charge button failure.There was no patient involvement.

Manufacturer Narrative

Provided results.H3 other text : customer would not return follow up calls.

Event Description

It was reported to philips that the device experienced a charge button failure.Multiple attempts have been made to obtain additional information but no response was received.Philips is unable to rule out that a malfunction did not occur.As additional information could not be obtained and an evaluation was not performed, a definitive cause for the alleged failure could not be determined.The device remains at the customer site and no further investigation or action is warranted.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 11602314
• MDR Text Key: 243349846
• Report Number: 3030677-2021-10596
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• 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,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
• Device Operator: Health Professional
• Device Model Number: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/08/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 03/08/2021; 09/14/2021
• Supplement Dates FDA Received: 04/29/2021; 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1