MAUDE Adverse Event Report: GETINGE SOURCING LLCGETINGE MODEL 433HC STEAM STERILIZER

Model Number 433HC

Event Date 07/01/2007

Event Type  Malfunction  

Manufacturer Narrative

Same device currently being evaluated at mfr to reproduce malfunction.

Event Description

A steam sterilizer released steam from the door while a tech was writing on a cycle tape dispensed from the printer which is located above the door. The sterilizer had indicated the chamber was empty of steam. The tech received a burn on his arm and had an antibiotic cream and dressing applied by a co-worker in the or. The tech then returned to work.

• Brand Name: GETINGE MODEL 433HC STEAM STERILIZER
• Type of Device: STEAM STERILIZER
• Manufacturer (Section F): GETINGE SOURCING LLC; rochester NY
• Manufacturer (Section D): GETINGE SOURCING LLC; rochester NY
• Manufacturer Contact: ann wheeler ; 1777 east henrietta rd.; rochester , NY 14623; (585) 272 -5036
• Device Event Key: 894881
• MDR Report Key: 910966
• Event Key: 873200
• Report Number: 1314329-2007-00004
• Device Sequence Number: 1
• Product Code: FLE
• Report Source: Manufacturer
• Source Type: User facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2007

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/10/2007
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Other
• Device MODEL Number: 433HC
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 08/02/2007
• Was Device Evaluated By Manufacturer?: No
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Invalid Data