MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-03 for 539-2105 manufactured by Precision Medical, Inc..
[3104342]
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Patient Sequence No: 1, Text Type: D, B5
[10498665]
In conclusion this error appears not to be a fault of the device, but of the care giver. The immediate solution would be training and vigilance, with long term, a standard correction, to the air flow meters and cannulas, forced across the industry by the fda and the (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523148-2012-00006 |
| MDR Report Key | 2897543 |
| Report Source | 06 |
| Date Received | 2012-12-03 |
| Date Reported to FDA | 2012-09-01 |
| Date Mfgr Received | 2012-11-28 |
| Date Added to Maude | 2013-01-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM PARKER |
| Manufacturer Street | 300 HELD DR. |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FLOW METER |
| Product Code | CAX |
| Date Received | 2012-12-03 |
| Catalog Number | 539-2105 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DR. NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-03 |