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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR
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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problems Battery Problem (2885); Device Sensing Problem (2917)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported to philips that the device's battery was not charging and was not recognized by the device.The alleged failure was observed while the device was in use on a patient, however, no adverse patient impact was reported by the customer.
 
Manufacturer Narrative
Additional info: b5 - added failure.Analysis info 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 device's battery was not charging and was not recognized by the device.The alleged failure was observed while the device was in use on a patient, however, no adverse patient impact was reported by the customer.One mrx battery was returned for failure analysis.The battery, (received without any charge), was able to charge (in both mrx heartstart unit and cadex c7200 battery analyzer), calibrate, and seemed to operate normally.The battery mode cf flag was set when the battery was received, indication that the battery needed to be calibrated.Battery calibration was successfully performed and resulted in a battery capacity of 96%.There is no fault found with this battery functionality wise.
 
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Brand Name
HEARTSTART MRX
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key11272000
MDR Text Key231118330
Report Number1218950-2021-00740
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838000018
UDI-Public(01)00884838000018
Combination Product (y/n)N
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3535A
Device Catalogue NumberM3535A
Device Lot Number20041-0241-P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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