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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 733HC STERILIZER, STEAM

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GETINGE IC PRODUCTION POLAND SP. Z O.O. 733HC STERILIZER, STEAM Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by manufacturing site. (b)(4).
 
Event Description
On (b)(6) 2019 getinge became aware of an issue with one of the sterilizers- 733hc. It was stated that the carriage has not latch to the device properly and cart fell into the floor. There was no injury reported however it was decided to report this issue based on the potential as any carts falling off from the device might lead to an adverse event. (b)(4).
 
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Brand Name733HC
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 Key8602913
MDR Text Key144849126
Report Number3012068831-2019-00002
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 Replace
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2019
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 Received05/06/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/06/2018
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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