MAUDE Adverse Event Report: GE CO. GE OMNIBED GIRAFFE INCUBATOR/WARMER; WARMER, INFANT RADIANT

Model Number 66500004901

Device Problems Microbial Contamination of Device (2303); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 05/25/2018

Event Type  malfunction  

Event Description

We currently have 6 ge omnibed giraffe incubators/warmers.All have a permanent seal around the lid; on (b)(6) when cleaning the inside of one of the incubator noted to have a blackish substance on the inside around the seal area.Cultures obtained and sent to lab - 2 of 3 growth of gram negative rod serratia marcescens.All beds taken out of service, dismantled, cleaned with oxycide cleaner and bioquell done.Ge was notified of issue and stated they had a "retro fit" kit that could be purchased that would eliminate the issue with a permanent seal.We were not previously aware of any received notification from ge the fixed seal could be a potential issue or a retro fit kit was available.We purchased retro fit kits for all of the incubators involved.We feel that ge should have made users aware that this is a potential issue; what i potential fix to the issue is; and those who have purchased the machine already should not have to purchase a retro fit kit.

• Brand Name: GE OMNIBED GIRAFFE INCUBATOR/WARMER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): GE CO.
• MDR Report Key: 7586337
• MDR Text Key: 110795144
• Report Number: MW5077713
• Device Sequence Number: 2
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/06/2018
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66500004901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 YR