MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-19 for BIRD GRAPHICS MONITOR manufactured by Cardinal Health.
[1101462]
Respiratory therapist placed infant on a bvip ventilator. The ventilator and the ventilator alarms were functioning. The graphic monitor was not functioning. Respiratory therapist attempted to check the electric source for the graphic monitor when there was a spark and then smoke. The infant was immediately removed from the ventilator and ventilated with a bag valve mask. A new ventilator was obtained, all systems checked and functional and the infant was placed on ventilator. No adverse outcome to infant or other infants/staff present in the nicu. Biomedical stated where the power cord goes into the fuse block the fuse block cracked in half causing the two wires to short together.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011626 |
| MDR Report Key | 1407138 |
| Date Received | 2009-06-19 |
| Date of Report | 2009-06-19 |
| Date of Event | 2009-06-15 |
| Date Added to Maude | 2009-06-30 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIRD GRAPHICS MONITOR |
| Generic Name | MONITOR |
| Product Code | BZQ |
| Date Received | 2009-06-19 |
| Returned To Mfg | 2009-06-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1100 BIRD CENTER DR PALM SPRINGS CA 92262 US 92262 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-06-19 |