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

Model Number	M3535A
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the battery malfunctioned.There was no patient involvement.
Event or Problem Description
It was reported to philips that the battery malfunctioned.The customer worked with the technical support representative.The customer confirmed the need for a battery exchange.The reported problem was verified in the lab.The battery pack was unable to charge either in heartstart mrx device or a cadex charger.Troubleshooting conducted revealed fuse f1 open.The fuse was replaced and the battery operated as normal.The customer was sent a battery replacement.The battery is customer replaceable.No further action at this time.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• 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: elizabeth proctor ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12390417
• Report Number: 3030677-2021-14007
• Device Sequence Number: 17059208
• Product Code: MKJ
• UDI-Device Identifier: 00884838002791
• UDI-Public: 00884838002791
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K031187
• Number of Events Summarized: 1
• Summary Report (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: M3535A
• Device Catalogue Number: M3535A
• Device Lot Number: 19221-0374-P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 12/14/2021
• 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