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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 533HCMC STERILIZER, STEAM

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GETINGE IC PRODUCTION POLAND SP. Z O.O. 533HCMC STERILIZER, STEAM Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2019
Event Type  malfunction  
Manufacturer Narrative
The issue is still being investigated by manufacturing site. Other text : device not returned to manufacturer.
 
Event Description
On (b)(6), 2019 getinge became aware of an issue with one of steam sterilizers ¿ 533hcmc. As it was stated by the customer, in the middle of the cycle the steam started to burst out and filled the room. There was no injury reported however we decided to report the issue based on the potential as any unexpected steam leak for parts available for the user might be a source of injury.
 
Manufacturer Narrative
The manufacturer was incorrectly chosen therefore, the number of the report was incorrect. Reporting will be continued under manufacturer report number 3012068831-2019-00011.
 
Event Description
Manufacturer reference number (b)(4).
 
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Brand Name533HCMC
Type of DeviceSTERILIZER, STEAM
Manufacturer (Section D)
GETINGE IC PRODUCTION POLAND SP. Z O.O.
szkolna 30
plewiska wielkopolskie
Manufacturer (Section G)
PASCAL JAY - MAQUET SAS
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
FR 45074
Manufacturer Contact
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
0332382587
MDR Report Key9070136
MDR Text Key175198917
Report Number9710055-2019-00271
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 Inspection
Type of Report Initial,Followup
Report Date 09/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received08/29/2019
Was Device Evaluated by Manufacturer? No
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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