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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 700-SERIES STERILIZER, STEAM

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GETINGE IC PRODUCTION POLAND SP. Z O.O. 700-SERIES STERILIZER, STEAM Back to Search Results
Model Number 733HC-E
Device Problem Device Fell (4014)
Patient Problem Bone Fracture(s) (1870)
Event Date 07/18/2021
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On (b)(6) 2021 getinge became aware of issue with transfer trolley used with 733hc-e sterilizer. As it was stated by the technician customer complained that when cart is on the trolley and the trolley is not hooked to the sterilizer, the cart can jump out of the wheel track. Customer stated that due to this situation items felt and caused an injury. Operator broke his toe. We decided to report the issue based on the information as such situation lead to serious injury. During the visit, getinge technicians have performed adjustment of locking mechanism of the trolley and they leveled trolley caster. Trolley was tested and confirmed to be fully functional.
 
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Brand Name700-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 Key12859728
MDR Text Key281134089
Report Number3012068831-2021-00004
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number733HC-E
Device Catalogue Number7CRVUPHTTAAA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/20/2020
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/23/2021 Patient Sequence Number: 1
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