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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL DEFIBRILLATOR

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PHILIPS MEDICAL SYSTEMS HEART START XL DEFIBRILLATOR Back to Search Results
Model Number M4735A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that a patient experienced a "burn" during a cardioversion procedure. A description and photographs of the reported burn, energy levels and number of shocks delivered, and whether treatment was required for this patient have been requested, but not yet received. Redness of the skin is an expected observation with the delivery of energy via pads. As we do not have any additional information we are considering this to be a serious injury.
 
Event Description
It was reported to philips that while using the heartstart xl monitor / defibrillator, a patient experienced a "burn" during a cardioversion procedure. The device was reported to be in use on a patient, but no adverse event to patient or user was reported. This complaint has been updated from a serious injury to a non adverse event.
 
Manufacturer Narrative
(b)(4) is being considered a duplicate of (b)(4) as the serial numbers are the same and the event was reported through two different sources. Refer to (b)(4) and mdr 1218950-2018-09608 for details on the investigation and conclusion of this case. This mdr (above) coded identical to mdr 1218950-2018-09608.
 
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Brand NameHEART START XL
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
bethany glynn
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8240331
MDR Text Key132819775
Report Number1218950-2019-00355
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K001725
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM4735A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/03/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/11/2019 Patient Sequence Number: 1
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