MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-17 for INFANT TRANSPORT INCUBATOR A750I * manufactured by International Biomedical Inc..
[3790921]
Manufacturer replaced battery with an older one. On (b)(4) 2013 the battery was replaced on this unit. The unit was purchased in january 2012 and upon replacing this battery on (b)(4) 2013, the battery being replaced had a 6/2011 sticker on it. On (b)(4) 2013 the battery was replaced again from the battery that was installed on (b)(4) 2013. Both batteries were purchased directly from the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3431523 |
| MDR Report Key | 3431523 |
| Date Received | 2013-10-17 |
| Date of Report | 2013-10-17 |
| Date of Event | 2013-09-20 |
| Report Date | 2013-10-17 |
| Date Reported to FDA | 2013-10-17 |
| Date Reported to Mfgr | 2013-10-28 |
| Date Added to Maude | 2013-10-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFANT TRANSPORT INCUBATOR |
| Generic Name | INCUBATOR, NEONATAL TRANSPORT |
| Product Code | FPL |
| Date Received | 2013-10-17 |
| Model Number | A750I |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL BIOMEDICAL INC. |
| Manufacturer Address | 8206 CROSS PARK DR AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-17 |