MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-31 for GIRAFFE INCUBATOR; GIRAFFE INCUBATOR + SHUTTLE M1143651 manufactured by Ohmeda Medical.
[84108820]
Patient Sequence No: 1, Text Type: N, H10
[84108821]
While preparing the infant for in-house transport to the procedure area, the transport team noticed that the infant transport shuttle displayed an amber light on both the left and right sides of the battery charge display indicator. The staff was aware that the shuttle was connected to an ac outlet and charging for at least 24 hours. The staff noted that this same shuttle did not complete the last transport because of the ups power dropping off and preventing operation of the isolette. Shuttle returned and biomedical contacted for service. Biomedical confirmed that the left led display indicated 4 green and 1 amber bar indicating the shuttle had less than 40 minutes of charge left as well a solid amber light on the right "caution" display indicating "recharge battery". Biomedical reviewed equipment history and noted that the battery pack was replaced almost a year ago and that the shuttle system had to have the charger board reset according to manufacturer recommendations on 3 separate occasions. Biomedical noted a previous medwatch report on a different serial number with the same user complaint. Both systems were included in a manufacturer recall action that involve the same charging issues. Manufacturer response for isolette transport system, giraffe shuttle (per site reporter): awaiting manufacturers response and direction on next steps for this re-occurring issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6833677 |
| MDR Report Key | 6833677 |
| Date Received | 2017-08-31 |
| Date of Report | 2017-08-29 |
| Date of Event | 2017-08-22 |
| Report Date | 2017-08-29 |
| Date Reported to FDA | 2017-08-29 |
| Date Reported to Mfgr | 2017-08-29 |
| Date Added to Maude | 2017-08-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 INCUBATOR; GIRAFFE INCUBATOR + SHUTTLE |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2017-08-31 |
| Model Number | M1143651 |
| ID Number | GIRAFFE SHUTTLE |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-08-31 |