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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 Communication or Transmission Problem (2896)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is completed.
 
Event Description
It was reported to philips that the device had no ecg signal. There was no patient involvement.
 
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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
daniel derochers
22100 bothell everett hwy
bothell, WA 98021
9786871501
MDR Report Key10013464
MDR Text Key189730537
Report Number1218950-2020-02560
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,Followup
Report Date 04/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2020
Is this an Adverse Event Report? No
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 Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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