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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEART START XL; DEFIBRILLATOR
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PHILIPS NORTH AMERICA LLC HEART START XL; DEFIBRILLATOR Back to Search Results
Model Number M4735A
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2022
Event Type  malfunction  
Event Description
It was reported to philips that the device's corner of the screen can't display.There was reportedly no patient involvement.
 
Manufacturer Narrative
The manufacturer's authorized field service engineer (fse) evaluated the device and confirmed the reported problem.Upon conclusion of the evaluation, it was determined that this was a malfunction of the display(cracked), which was replaced, and the device was returned to full functionality.The device remains at the customer site and no further evaluation is warranted at this time.
 
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Brand Name
HEART START XL
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
daniel derochers
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key15086299
MDR Text Key296415343
Report Number3030677-2022-03650
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K021453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM4735A
Device Catalogue NumberM4735A
Is the Reporter a Health Professional? No
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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