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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GETINGE USA, INC.; STERILIZER, STEAM

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GETINGE USA, INC.; STERILIZER, STEAM Back to Search Results
Model Number 633HC
Device Problems Device Operates Differently Than Expected (2913); Naturally Worn (2988)
Patient Problem No Information (3190)
Event Date 08/23/2017
Event Type  malfunction  
Event Description
Per the getinge rep report: "customer is getting intermittent failed bio's on their incubator.The failures occur mainly on the first cycle of the day and when using well #2 in the 3m incubator.One failure occurred in well #7 but that vial did change to the correct color of a negative test.I checked the components of the sterilizer but did not find any problems other than some wear on the door gasket which i replaced.I ran a leak test.The unit pulled a vacuum down to.30psi.The goal is less than 1psi.The cycle finished at.31psi, losing.01psi.The goal is to lose less than.75psi.The getinge consumable rep is bringing in biological test packs and an incubator to run tests along with the current product.The customer will also use different wells in their incubator to rule out well #2.Manufacturer response for biological control incubator, 3m attest rapid 5 (per site reporter).The getinge consumable rep is bringing in biological test packs and an incubator to run tests along with the current product to verify the issue.
 
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Type of Device
STERILIZER, STEAM
Manufacturer (Section D)
GETINGE USA, INC.
dennis genito
45 barbour pond dr
wayne NJ 07470
MDR Report Key6948178
MDR Text Key89279520
Report Number6948178
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/31/2017,09/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number633HC
Other Device ID Number3873
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/31/2017
Device Age10 YR
Event Location Hospital
Date Report to Manufacturer08/31/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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