MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-12 for GIRAFFE OMNIBED manufactured by Ohmeda Medical.
[85808887]
Patient Sequence No: 1, Text Type: N, H10
[85808888]
Micro-preemie day-of-life (dol) 4 infant required temperature regulation and 80% humidified air. Isolette porthole door hinge broken. Due to prematurity and temp/humidity regulation infant left in isolette until she did not require such strict high air temperature and humidity. Unfortunately, the door hinge broke off entirely and isolette needed to be changed prior to dol 10. Infant tolerated isolette change well. The temp remained stable, no new skin issues noticed. Nicu staff and clinical engineering (ce) have been noticing and increased failure rate with the new ge omni bed porthole doors. Ce has trended the porthole door failures and has seen an average failure rate of (b)(4) broken doors per month or (b)(4) broken doors per week over a 6 month period. Typically the broken doors are found before putting an infant in the unit. However, this incident is evidence this failure needs to be escalated to the fda due to the potential harm to the patient. Additionally, clinical engineering has noticed an overall larger failure rate with the ge omni beds, tracking (b)(4) incidents of service over an 8 month period. This is a drastically increased rate of failure compared to the previous version of ge omni beds that our hospital used before upgrading. Ce and nicu have been working with ge on these service issues. Ge has come on site to observe the workflow to see if a root cause of the failures could be determined. Results were inconclusive. Additionally, ce did our own engineering analysis and submitted the results to ge. Ge analyzed the results from our hospital and presented us with their findings late-(b)(6) and essentially admitted there was a design flaw with the new port hole door hinge cover.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6857816 |
| MDR Report Key | 6857816 |
| Date Received | 2017-09-12 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-05-09 |
| Report Date | 2017-08-28 |
| Date Reported to FDA | 2017-08-28 |
| Date Reported to Mfgr | 2017-08-28 |
| Date Added to Maude | 2017-09-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIRAFFE OMNIBED |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2017-09-12 |
| Model Number | OMNIBED |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-09-12 |