MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problems Fitting Problem (2183); Battery Problem (2885); Power Problem (3010)

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

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

Reporting institution phone: (b)(6).Reporter phone:.

Event Description

It was reported that the battery has a faulty connector.It is unknown if the device was being used on a patient at the time of the issue, but no adverse event to a patient or user was reported.

Manufacturer Narrative

The customer evaluated the device and received remote support from the customer care solution center, during which a quote was provided for the replacement of the battery pca.Upon conclusion of the evaluation, it was determined that this was a malfunction of the battery pca for which a quote was provided for replacement.The device remains at the customer site and no further evaluation is warranted at this time.

Event Description

This complaint has been deemed a duplicate of (b)(4) already reported on mdr number 3030677-2022-03754.Based on good faith effort details received from the customer regarding (b)(4), it was confirmed on (b)(6) 2022 that the patient died.In addition, the event date in (b)(4) has been updated to (b)(6) 2022, and the become aware date and philips notified date have been updated to 20jun2022.

Manufacturer Narrative

This complaint has been deemed a duplicate of (b)(4) already reported on mdr number 3030677-2022-03754.Based on good faith effort details received from the customer regarding (b)(4), it was confirmed on (b)(6) 2022 that the patient died.In addition, the event date in (b)(4) has been updated to (b)(6) 2022, and the become aware date and philips notified date have been updated to 20jun2022.

Manufacturer Narrative

Correction: this report was sent on 30aug2022 as a duplicate of (b)(4) (already reported on mdr number 3030677-2022-03754).However, after additional review, it has been determined that this is a separate additional issue and not a duplicate.

Event Description

It was reported the device was not powering on and off during servicing.There was no patient involvement.A philips authorized service provider (asp) evaluated the device.The asp stated that one battery supplied with the unit was faulty but also found that the unit has an issue with the battery pca.The asp determined the battery pca and battery were faulty, which was causing the unit to not recognize the battery and this caused the shutting down of the unit whether the battery was full or not.The asp provided two quotes to the customer for replacement of the battery and the battery pca.The quotation for the repair was not accepted and the quote expired after 30 days.Therefore, no work was performed on this device as the quote was not accepted.The device remains at the customer site and no further evaluation is warranted at this time.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: 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: laura scanlan ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 14978291
• MDR Text Key: 295639979
• Report Number: 3030677-2022-03434
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1