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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 Problems Failure to Charge (1085); Failure to Deliver Shock/Stimulation (1133); Improper or Incorrect Procedure or Method (2017)
Patient Problems Low Blood Pressure/ Hypotension (1914); Loss Of Pulse (2562)
Event Date 10/06/2020
Event Type  Death  
Manufacturer Narrative
Medwatch uf/importer report#: (b)(4).
 
Event Description
It was reported to philips that a patient was post-op vasoplegia when, upon entrance to room lost blood pressure and was pea (pulseless electrical activity) arrested. The doctor and rn were running the defibrillator and hey finally got the patient into ventricular fibrillation. The device was unable to charge or deliver a shock. The cable connections were checked which were fine. After checking the defibrillator, it was noted that the device was in sync mode. The rn was trying to cardiovert the patient instead of defibrillating, but did not recognize this. By the time the users switched over and charged again, the patient already had gone back into pea. The patient died. No ecg monitoring strips or case event files were provided to philips for review. The customer clinical engineering department evaluated the device and stated the unit was fully functional with no problems found during testing including the system log was retrieved and there were no errors showing related to this incident. Philips did not evaluate the device. It was determined by the customer that this was operator error, not an equipment failure. Additionally the customer no longer uses the defibrillator.
 
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Brand NameHEART START XL
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
bothell WA 98021
Manufacturer Contact
jacqueline nishino
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key11167948
MDR Text Key226759451
Report Number1218950-2021-00250
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001725
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
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?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2004
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: 01/13/2021 Patient Sequence Number: 1
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