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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 122 STERILIZER, STEAM

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GETINGE IC PRODUCTION POLAND SP. Z O.O. 122 STERILIZER, STEAM Back to Search Results
Model Number 122
Device Problem Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by manufacturing site. H3 other text : device not returned to the manufacturer.
 
Event Description
On 19th september, 2019 getinge became aware about an issue with 122hc steam sterilizer. As it was stated by the customer, blue instrument wrap, autoclave bottle caps and stoppers were disintegrating in the device after the cycle. During the inspection it was found that customer was being used the signle use wraps, caps and stppers more time than one. Moreover, it was noted that customer was occasionally leaving loads in the device over night or over the weekend. There was no injury reported and no malfunction on the device observed, however it was decided to report this issue in abundance of caution, as incorrectly prepared load for sterilization and stored after the process could be used on the patient treatment leading to contamination.
 
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Brand Name122
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 Key9109729
MDR Text Key216934640
Report Number3012068831-2019-00012
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 Inspection
Type of Report Initial,Followup,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number122
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 Received11/18/2019
Was Device Evaluated by Manufacturer? No
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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