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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE (SUZHOU) CO., LTD DURADIAGNOST SYSTEM, X-RAY, STATIONARY

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PHILIPS HEALTHCARE (SUZHOU) CO., LTD DURADIAGNOST SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number 712214
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Overdose (1988)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still ongoing for this event. When the investigation is completed a follow-up will sent to the fda.
 
Event Description
The system had error message ¿call service- generator failed¿, patient received overdose.
 
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Brand NameDURADIAGNOST
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
PHILIPS HEALTHCARE (SUZHOU) CO., LTD
no.258, zhongyuan road
suzhou industrial park
suzhou 21502 4
CH 215024
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
dusty leppert
no.258, zhongyuan road
suzhou industrial park
suzhou 21502-4
CH   215024
MDR Report Key8878363
MDR Text Key154033565
Report Number3009529630-2019-00001
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K141381
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number712214
Device Catalogue Number712214
Device Lot NumberSN180054
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 Received07/12/2019
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

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