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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z.O.O. 433HC

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GETINGE IC PRODUCTION POLAND SP. Z.O.O. 433HC Back to Search Results
Device Problems Fluid Leak (1250); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The issue is being investigated by manufacturing site.
 
Event Description
On (b)(6) 2018 we became aware of an incident with one of steam sterilizers- 433hc. As stated by the customer, the door gasket popped out and steam and water spit on user. There is no injury reported. To date we did not receive any information about the water and steam temperature however we decided to report the issue in abundance of caution as an unexpected hot steam or water leak may lead to adverse event.
 
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Brand Name433HC
Type of Device433HC
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 Key8023278
MDR Text Key125659890
Report Number3012068831-2018-00012
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,health
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial,Followup,Followup
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2018
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? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received10/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/31/2018 Patient Sequence Number: 1
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