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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 Handling Problem (3265)
Patient Problem Injury (2348)
Event Date 10/22/2019
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by the manufacturing site. Device not returned to manufacturer.
 
Event Description
On (b)(6) getinge became aware about an incident when load rack came off trolley when the operator was unloading the sterilized items. The trolley moved away, hurting operators' arm. The harm was not clasified as serious, however we decided to report this case as the potential risk of the serious injury.
 
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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 Key9244153
MDR Text Key201685708
Report Number3012068831-2019-00013
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 Repair
Type of Report Initial,Followup,Followup
Report Date 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number733HC-E
Device Catalogue NumberUNKNOWN
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 Received04/06/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/13/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/28/2019 Patient Sequence Number: 1
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