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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP.Z O.O. 833 HC 833HC

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GETINGE IC PRODUCTION POLAND SP.Z O.O. 833 HC 833HC Back to Search Results
Device Problem Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/15/2019
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by manufacturing site. (b)(4).
 
Event Description
On (b)(6) 2019 (b)(4) became aware of an issue with one of the devices manufactured by (b)(4)- 833 hc steam sterilizer. As it was stated, the steam leak occurred through door not fully closed. There was no injury reported, however it was decided to report the issue based on the potential as any unexpected steam leak from parts of the device available for the customer might lead to serious injury or worse.
 
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Brand Name833 HC
Type of Device833HC
Manufacturer (Section D)
GETINGE IC PRODUCTION POLAND SP.Z O.O.
ul. szkolna 30
plewiska, plewiska 62064
PL 62064
Manufacturer (Section G)
GETINGE IC PRODUCTION POLAND SP.Z O.O.
ul. szkolna 30
plewiska, plewiska 62064
PL 62064
Manufacturer Contact
dennis genito
45 barbour pond drive
wayne 07470
9737097515
MDR Report Key8508240
MDR Text Key141749769
Report Number3012068831-2019-00001
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup,Followup,Followup
Report Date 07/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2019
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? No
Event Location Hospital
Date Manufacturer Received04/06/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/22/2013
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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