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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

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GETINGE IC PRODUCTION POLAND SP. Z.O.O. 733HC Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problem Injury (2348)
Event Date 11/21/2018
Event Type  Injury  
Manufacturer Narrative

The issue is being investigated by manufacturing site. (b)(4).

 
Event Description

On (b)(4) 2018 we became aware of an incident with one of devices-733hc. It was stated that trolley used with this product dislodged from the sterilizer and rolled back before the car was fully unloaded. The technician who operated this device attempted to lift the car back onto the trolley injured the back. The injury required medical intervention.

 
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Brand Name733HC
Type of Device733HC
Manufacturer (Section D)
GETINGE IC PRODUCTION POLAND SP. Z.O.O.
szkolna 30
plewiska, 62-06 4
PL 62-064
Manufacturer (Section G)
GETINGE IC PRODUCTION POLAND SP. Z.O.O.
szkolna 30
plewiska, 62-06 4
PL 62-064
Manufacturer Contact
dennis genito
45 barbour pond drive
wayne, NJ 07470
9737097515
MDR Report Key8189030
MDR Text Key131139863
Report Number3012068831-2018-00013
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation ADMINISTRATOR/SUPERVISOR
Remedial Action Repair
Type of Report Initial,Followup,Followup
Report Date 01/16/2019,02/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/16/2019
Distributor Facility Aware Date11/26/2018
Event Location Hospital
Date Manufacturer Received11/26/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/16/2007
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: 12/21/2018 Patient Sequence Number: 1
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