MAUDE Adverse Event Report: OHMEDA MEDICAL GIRAFFE OMNIBED; NEONATAL INCUBATOR

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

The premature infant with the positive bloodstream infection was (b)(6) at time of incident of finding the reported black sticky substance, weighed (b)(6) at birth and (b)(6) at time of the incident and is male.The range of gestational ages at birth of the babies who were colonized was (b)(6), their weight range was 590-800gms.Report source: user report mw5077713.Device identification number and date of device manufacture: the reported serial numbers and respective dates of manufactures are as follows: (b)(4): december 2002, (b)(4): june 2007, (b)(4): july 2007, (b)(4): april 2008, (b)(4): nov 2010, (b)(4): sept 2012.Device evaluation anticipated, but not yet begun.

Event Description

Six omnibeds in use for premature infants from one site were found to have a black sticky substance under the canopy seal.The black sticky substance was cultured and grew serratia marcescens.The 6 premature infants currently using the omnibeds were cultured with surface swabs (rectal) and blood cultures.Two infants were negative for all cultures; three infants were found to be colonized and had positive surface swabs; and one infant had a positive blood culture indicating bloodstream infection.The 3 colonized infants and the infant with the positive blood culture were treated with a course of antibiotics.One of the colonized infants died as a result of comorbidities and was not related to serratia marcescens according to the customer medical staff.It could not be determined which infant was in each affected omnibed at the time of the incident.

Manufacturer Narrative

Ge healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately per giraffe omnibed cleaning and care guidelines on systems with original seal design.Reported buildup of debris around the edge of the canopy seal can lead to a source of infection.Ge healthcare (gehc) is initiating and will be reporting a field modification for this issue per 21 cfr 806.The gehc internal field modification number is (b)(4).

• Brand Name: GIRAFFE OMNIBED
• Type of Device: NEONATAL INCUBATOR
• Manufacturer (Section D): OHMEDA MEDICAL; 8880 gorman rd; laurel, MD 20723
• MDR Report Key: 7705876
• MDR Text Key: 114559346
• Report Number: 1121732-2018-00007
• Device Sequence Number: 1
• Product Code: FMZ
• Combination Product (y/n): N
• PMA/PMN Number: K101788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: GEHC FMI 32063
• Patient Sequence Number: 1
• Patient Outcome(s): Other