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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE MULTIDIAGNOST ELEVA WITH FLAT SYSTEM, X-RAY, STATIONARY

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PHILIPS HEALTHCARE MULTIDIAGNOST ELEVA WITH FLAT SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number 708034
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Date 09/30/2017
Event Type  Death  
Manufacturer Narrative
Philips analyzed the logging and noticed a crystallographic image processing ( crisp) image pc warning that an export task did not start. No additional information is present in the logging. The non-functional crisp could have been the reason why the md eleva did not start-up. Since the system did not start-up, no other logging information is available. No investigation could be done on the crystallographic image processing (crisp) as the part was not available for analysis. The crystallographic image processing (crisp) was replaced and this solved the problem. Search on replaced parts in the past for this system show that this is the first time that the ip pc has been replaced. The system was installed in 2007 and therefore we conclude that this normal wear and tear after 10 years. Trend data of this part does not show any exceptional replacement rate. No similar complaints have been identified. No additional actions will be taken.
 
Manufacturer Narrative
Image processing pc malfunctioned when the investigation has been completed philips will inform the fda.
 
Event Description
Philips received a complaint in which it was stated that a patient was going to receive an emergency procedure with a multi diagnost eleva system. As the system did not start properly, the patient was transferred to another room where the patient was treated. The procedure was finished and the patient was returned to the resuscitation department. Later the patient died. According to the medical staff the delay in treatment could have contributed to the outcome of the patient. The hospital is also investigating the cause of the death.
 
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Brand NameMULTIDIAGNOST ELEVA WITH FLAT
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
PHILIPS HEALTHCARE
veenpluis 4-6
p.o. box 10.000
best 5680 DA
NL 5680 DA
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
dusty leppert
veenpluis 4-6
p.o. box 10.000
best 5680 -DA
NL   5680 DA
MDR Report Key6933987
MDR Text Key106048475
Report Number3003768277-2017-00084
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K961374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number708034
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/10/2017 Patient Sequence Number: 1
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