MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-25 for O2 FLOW METER - FOR 15LPM OF FLOW manufactured by Precision Medical.
[16583090]
While staff were attempting to bag the pt via mapleson, it appeared that the o2 flow was not correct despite the flow meter ball moving. Device was making a whistle sound. Device was removed from service and replaced with a new one. The device has been returned to the mfr for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019567 |
| MDR Report Key | 2004004 |
| Date Received | 2011-02-25 |
| Date of Report | 2011-02-16 |
| Date of Event | 2011-02-12 |
| Date Added to Maude | 2011-03-08 |
| 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 |
| Generic Name | O2 FLOW METER - FOR 15LPM OF FLOW |
| Product Code | BZH |
| Date Received | 2011-02-25 |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-25 |