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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 Poor Quality Image (1408)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
It was reported to philips that the device's screen was not bright. It was reported to philips that the alleged failure was observed while the device was in use on a patient. However, no adverse patient impact was reported by the customer.
 
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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 Key6551014
MDR Text Key74798896
Report Number1218950-2017-03006
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K001725
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2017
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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