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 with all five led indicators illuminated suggesting the battery was received with 80% capacity at minimum.A voltage measurement test was completed and it was noted that the measured voltage between pin 1 and pin 4 was 16.01v.The battery was then inserted in a known working mrx unit and the device began chirping.The rfu indicator showed a black flashing hourglass and a solid red x at repetitive frequency as is the case when there is no battery installed in the unit.Furthermore, both the battery compartments showed empty when the device was turned on despite the battery being inserted.The battery was then installed in cadex c7200 battery analyzer and seemed to be accepting charge.Although the battery had all five leds permanently lit it still would not power up the mrx unit.Battery calibration was attempted using the mrx reference unit but each time, the battery was requested to be inserted although it was already installed in the unit.Upon conclusion of the analysis, the reported problem was verified and it was confirmed that the battery was faulty.

Manufacturer Narrative

Upon response from the vendor, it was verified that the battery for the unit failed due to an open f1 fuse coinciding with a pack overdischarge.Upon placing a jumper in the f1 fuse and applying a wake up voltage, it was found that the cells were in an undervoltage condition.This caused multiple flags to activate, which disables communication and voltage output.No further evaluation was requested.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

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

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9536433
• MDR Text Key: 177938913
• Report Number: 1218950-2019-09927
• Device Sequence Number: 1
• Product Code: MKJ
• 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
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1