MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problem Failure to Charge (1085)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported to philips that the battery for the device won't charge ((b)(4)).There was no patient involvement.

Manufacturer Narrative

Updated with failure analysis evaluation.Updated section "return to manuf.?" and "date returned to manuf." to coincide with the product return.Updated codes to reflect failure analysis results.

Event Description

It was reported to philips that the battery for the device won't charge ((b)(4)).There was no patient involvement.The battery was returned to the failure analysis lab for evaluation.The battery was visually inspected for any mechanical damage and/or contamination, and no anomalies were found.The battery was received without any charge but was able to charge in both the mrx heartstart unit and cadex c7200 battery analyzer.After charging the battery, the unit operating on battery power only (ac power removed) was able to successfully deliver all attempted shocks and the delivered energy was measured within passing range.The battery was also successfully calibrated and the capacity was confirmed to be within range.Upon conclusion of the analysis, the reported issue could not be verified.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: daniel derochers ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9536448
• MDR Text Key: 177938905
• Report Number: 1218950-2019-09929
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• 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