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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDMARK CORP. RITTER; PROCEDURE LIGHT
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MIDMARK CORP. RITTER; PROCEDURE LIGHT Back to Search Results
Model Number 355-028
Device Problem Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2014
Event Type  malfunction  
Event Description
Customer stated that midmark 355 light had (4) mounting screws shear and the light fell from its ceiling mounting.No injuries occurred.
 
Manufacturer Narrative
Photographic evidence was evaluated and showed that components of the midmark 355 light were modified by someone other than midmark.It is unk if this adulteration contributed to the failure.Additional testing was performed on a similar midmark 355 light and found no failure would occur with normal use and preventative maintenance.Notification was given to the customer on what normal use and preventative maintenance is required for this device.
 
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Brand Name
RITTER
Type of Device
PROCEDURE LIGHT
Manufacturer (Section D)
MIDMARK CORP.
versailles OH
Manufacturer Contact
craig rammel
60 vista dr.
versailles, OH 45380
9375263662
MDR Report Key4281453
MDR Text Key21719572
Report Number1523530-2014-00016
Device Sequence Number1
Product Code EAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Remedial Action Inspection
Type of Report Initial
Report Date 11/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number355-028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received10/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2005
Type of Device Usage Reuse
Patient Sequence Number1
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