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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP Z O O GETINGE STERILIZER, STEAM

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GETINGE IC PRODUCTION POLAND SP Z O O GETINGE STERILIZER, STEAM Back to Search Results
Model Number 733HC
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2017
Event Type  malfunction  
Event Description
Getting sterilizer #3, model 733hc-e, vacuum/gravity steam sterilizer malfunctioned about a month ago. Clinical engineering was called and eventually the getting service representative was contacted. It was determined that new valves for the sterilizer were needed. The valves were ordered and should be installed tomorrow.
 
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Brand NameGETINGE
Type of DeviceSTERILIZER, STEAM
Manufacturer (Section D)
GETINGE IC PRODUCTION POLAND SP Z O O
45 barbour pond dr.
wayne NJ 07470
MDR Report Key7178221
MDR Text Key96840295
Report Number7178221
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number733HC
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/29/2017
Event Location Hospital
Date Report to Manufacturer12/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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