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

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.

• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE USA, INC.; dennis genito; 45 barbour pond dr; wayne NJ 07470
• MDR Report Key: 6948178
• MDR Text Key: 89279520
• Report Number: 6948178
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: 633HC
• Other Device ID Number: 3873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2017
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2017
• 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 Number: 1