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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 43110A DEFIBRILLATOR/MONITOR

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PHILIPS MEDICAL SYSTEMS 43110A DEFIBRILLATOR/MONITOR Back to Search Results
Model Number 43110A
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The customer reported that the device had a blank display.There wa sno reported pt involvement.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
43110A DEFIBRILLATOR/MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810
Manufacturer Contact
nancy ataide
3000 minuteman rd.
andover, MA 01810
9786597429
MDR Report Key4236652
MDR Text Key4973548
Report Number1218950-2014-06578
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K844741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number43110A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/10/2014
Initial Date FDA Received10/31/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/1987
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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