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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE BV PULSERA, MOBILE X-RAY UNIT, R 2.3; FLUOROSCOPIC X-RAY SYSTEM
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PHILIPS HEALTHCARE BV PULSERA, MOBILE X-RAY UNIT, R 2.3; FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 718095
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Philips received a complaint from a customer in which they informed us about a technician who was plugging a system into wall power received an electric shock.The customer did not report any injury to the technician.
 
Manufacturer Narrative
(b)(4).When investigation is completed a follow up report will be sent to fda.
 
Manufacturer Narrative
Philips received the mains cable and the wired bracket, they have been investigated and they were according specifications.A philips field service engineer checked with the hospital maintenance department the power outlet in question and did not find any problems with it.Furthermore, the system was tested and found to be within the specifications, so we conclude there was no system malfunction.(b)(4).
 
Event Description
Philips received a complaint from a customer in which they informed us about a technician who was plugging a system into wall power received an electric shock.The customer did not report any injury to the technician.
 
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Brand Name
BV PULSERA, MOBILE X-RAY UNIT, R 2.3
Type of Device
FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
best 5680
NL  5680
Manufacturer Contact
dusty leppert
3000 minuteman rd
andover , MA 01810
9786597892
MDR Report Key4736604
MDR Text Key5821812
Report Number3003768277-2015-00034
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,company representative
Reporter Occupation Radiologic Technologist
Type of Report Initial,Followup
Report Date 03/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number718095
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2015
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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