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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 500-SERIES STERILIZER, STEAM

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GETINGE IC PRODUCTION POLAND SP. Z O.O. 500-SERIES STERILIZER, STEAM Back to Search Results
Model Number 533HC
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by the manufacturing site. Device not returned to manufacturer.
 
Event Description
On 16th october, 2019 getinge became aware of the problem with one of the sterilizers, 533-hc. The customer noticed the door did not open. When customer opened the door manually, steam issued from the chamber to the room. There was no injury reported, however we decided to report this event basing on the risk of potential serious injury or death.
 
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Brand Name500-SERIES
Type of DeviceSTERILIZER, STEAM
Manufacturer (Section D)
GETINGE IC PRODUCTION POLAND SP. Z O.O.
szkolna 30
plewiska wielkopolskie
Manufacturer (Section G)
GETINGE IC PRODUCTION POLAND SP. Z O.O.
szkolna 30
plewiska wielkopolskie
Manufacturer Contact
dennis genito
szkolna 30
plewiska wielkopolskie 
MDR Report Key9259394
MDR Text Key217439201
Report Number3012068831-2019-00014
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup,Followup,Followup
Report Date 04/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number533HC
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/17/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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