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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH PCR COMPANO BASIC SYSTEM SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

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PHILIPS MEDICAL SYSTEMS DMC GMBH PCR COMPANO BASIC SYSTEM SYSTEM, IMAGE PROCESSING, RADIOLOGICAL Back to Search Results
Model Number 732028
Device Problems Overheating of Device (1437); Smoking (1585)
Patient Problems Respiratory Distress (2045); No Code Available (3191)
Event Date 04/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The investigation is still ongoing on this event. When the investigation is completed a follow-up report will be sent to the fda.
 
Event Description
The customer complained, that the cr reader overheated causing smoke to fill emergency department, two persons of the staff inhaled smoke. According to information received one person was treated with 4liter of oxygen for 30 minutes. Furthermore blood work was done and one person apparently received a chest x ray.
 
Manufacturer Narrative
The computed radiography (cr) reader processes digital image plates, and sends the image data to the image acquisition system workstation for reviewing, post processing and archiving the clinical image. Visual inspection by the philips field service engineer showed that there was no visible evidence of burning of (a part of) the reader. For testing reason the reader was turned on by field service engineer. No smoke was detected, but the power supply emitted a burning smell within a few minutes of operation. The root cause of the issue points to a premature failure of an electrical component inside the power supply. The device is compliant to applicable standards like en 60601 1, en 60950, and ul/csa, which adequately address such hazards. The oxygen treatment to the two persons is considered a preventive measure, not a therapeutic one. Therefore this incident is finally not classified as a serious injury. Corrected data: adverse event or product problem (changed from adverse event and product problem to product problem). Type of reportable event (changed from serious injury to malfunction). (b)(4).
 
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Brand NamePCR COMPANO BASIC SYSTEM
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS DMC GMBH
roentgenstr. 24
hamburg 22335
GM 22335
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
dusty leppert
roentgenstr. 24
hamburg 22335
GM   22335
405078-229
MDR Report Key5627280
MDR Text Key44276213
Report Number3003768251-2016-00004
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K964124
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number732028
Device Catalogue Number732028
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 Received05/02/2016
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 Treatment Data
Date Received: 05/03/2016 Patient Sequence Number: 1
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