MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-07-20 for GIRAFFE OMNIBED manufactured by Ohmeda Medical.
[114559343]
The premature infant with the positive bloodstream infection was (b)(6) at birth and was (b)(6) at time of incident of finding the reported black sticky substance, (b)(6) at birth and 970 grams at time of the incident and is male. The range of gestational ages at birth of the babies who were colonized was 24-25 weeks, their weight range was 590-800 gms. 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.
Patient Sequence No: 1, Text Type: N, H10
[114559344]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121732-2018-00005 |
| MDR Report Key | 7705829 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-07-20 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-05-25 |
| Date Mfgr Received | 2018-08-31 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2018-07-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN SZALINSKI |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | GEHC FMI 32063 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIRAFFE OMNIBED |
| Generic Name | NEONATAL INCUBATOR |
| Product Code | FMZ |
| Date Received | 2018-07-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHMEDA MEDICAL |
| Manufacturer Address | 8880 GORMAN RD LAUREL, MD 20723 US 20723 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-20 |