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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICAN CORPORATION PHILIPS MEDICAL; DEFIBRILLATOR
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PHILIPS NORTH AMERICAN CORPORATION PHILIPS MEDICAL; DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Death (1802)
Event Date 06/04/2014
Event Type  Death  
Event Description
Pt was in mri when she coded.Cpr started immediately, pt taken out of safe zone.During code, rn reports charging/attempting 5 shocks; however, only one was delivered.Pads changed.Rn noticed during code "internal error" or "memory failure error" on the defibrillator screen.Strip confirmed only one shock was delivered.Another defibrillator requested, code continued, patient expired.Biomed department was able to replicate the following message by slight movement of the device: "device restarted.Alarm settings were restored.Other settings have been reset to default values." investigation completed on (b)(4) 2014 and determined needed to report to fda.
 
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Brand Name
PHILIPS MEDICAL
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS NORTH AMERICAN CORPORATION
andover MA
MDR Report Key3902373
MDR Text Key4652285
Report Number3902373
Device Sequence Number1
Product Code LDD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3535A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/20/2014
Distributor Facility Aware Date06/05/2014
Device Age5 YR
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age56 YR
Patient Weight61
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