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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDMARK CORP. MIDMARK; STEAM STERILIZER
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MIDMARK CORP. MIDMARK; STEAM STERILIZER Back to Search Results
Model Number M3-001
Device Problems Pressure Problem (3012); Noise, Audible (3273)
Patient Problem Burn(s) (1757)
Event Date 01/21/2015
Event Type  No Answer Provided  
Event Description
Original call from the user facility indicated a technician was working on a sterilizer and there was a "bang"; tray came out under pressure".Technician received burns.
 
Manufacturer Narrative
It is realized that the service technician did not service the unit as per midmark expectations per service bulletin dated on 09/18/2012.This bulletin indicates that in the event the technician is called to service a unit with a "stuck door" issue they are not to attempt to service or repair but to return the unit to midmark for full investigation and repair.This technician failed to accommodate this expectation and attempted to remove the tray and close the unit's door with the expectation of continued use.As of this date the unit has not yet been received at midmark.
 
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Brand Name
MIDMARK
Type of Device
STEAM STERILIZER
Manufacturer (Section D)
MIDMARK CORP.
versailles OH
Manufacturer Contact
jane carroll
60 vista dr.
versailles, OH 45380
MDR Report Key4544740
MDR Text Key5509050
Report Number1523530-2015-00001
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberM3-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/21/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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