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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 233HC STERILIZER, STEAM

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GETINGE IC PRODUCTION POLAND SP. Z O.O. 233HC STERILIZER, STEAM Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Pressure Problem (3012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2019
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by manufacturing site. (b)(4). Device not returned to the manufacturer.
 
Event Description
On 21th may, 2019 getinge became aware of an issue with one of the steam sterilizer- 233hc. It was stated that during the cycle when the chamber was pressurized the door opened suddenly and the steam leaked into the room. Moreover, at the time of release some instruments came out from the chamber. There was no injury reported, however it was decided to report this issue based on the potential as any unexpected door opening during the cycle could result in hazardous situation.
 
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Brand Name233HC
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
szkolna 30
plewiska wielkopolskie 
MDR Report Key8649111
MDR Text Key146344693
Report Number3012068831-2019-00003
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,Followup
Report Date 07/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/21/2019
Event Location Hospital
Date Manufacturer Received05/21/2019
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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