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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 Noise, Audible (3273)
Patient Problem Burn, Thermal (2530)
Event Date 01/09/2018
Event Type  Injury  
Manufacturer Narrative
It was reported to philips that an arc of energy delivered from the device burned the patient. The patient involved was reported to have experienced a burn injury when the device delivered energy for a cardioversion procedure. The clinicians reported the device made a clicking noise and an arc burnt the patient. The patient was treated for first degree burns to the chest. The users reported to the biomed the patient skin was not wet. The pads were not expired. The lot # and expiration date are unknown. The patient was a (b)(6) male who was being treated for atrial fibrillation with cardioversion in the emergency department (ed) on (b)(6) 2018. The cardioversion procedure was successful. The clinicians noted the arching heard a snap and first degree burn to the chest. Per the bedside rn the defib pads used for the procedure where placed in correct position, well adhering to the patient chest, and the patient chest wasn't wet. The customer is requesting that the device be returned for bench repair. The device was received by the philips bench repair on (b)(6) 2018. The bench repair was not able to reproduce the failure when performing the operational check test and found all tests passed. The bench repair reported that the issue was not confirmed and there was no trouble found with the device. The device passed all performance assurance testing and was returned to the customer to be placed back in service. Philips cannot rule out a malfunction of the device at the time it was reported. There is no indication of a systemic problem; no further investigation or action is warranted.
 
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete. Patient information was requested, not yet received.
 
Event Description
It was reported to philips that an arc of energy delivered from the device burned the patient. The patient involved was reported to have experienced a burn injury when the device delivered energy for a cardioversion procedure. The clinicians reported the device made a clicking noise and an arc burnt the patient. The patient required treatment for the burn. The users reported to the biomed the patient skin was not wet. The pads were not expired. The lot # and expiration date are unknown.
 
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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
richa shah
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key7206960
MDR Text Key104453845
Report Number1218950-2018-00657
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM4735A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/15/2010
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: 01/19/2018 Patient Sequence Number: 1
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