MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-06-12 for FM-15UA-OH manufactured by .
[2730500]
Event description: pt nasal cannula was connected to wall-piped medical air via flow meter with yellow color coded christmas tree nipple adapter instead of connected to wall oxygen via flow meter oxygen with green color christmas tree nipple adapter.
Patient Sequence No: 1, Text Type: D, B5
[9921479]
Amvex qa personnel ((b)(4)) spoke to initial reporter (b)(6) on (b)(4) at 3:00 pm regarding further explanation of incident as reported on medwatch report (b)(4). Based on further info, the flowmeter in question functioned as per our design and operational specifications. Medical staff did the initial hook up of the cannula and as described there was an error made by medical staff. The hook up of the nasal cannula was made to the medical air flowmeter rather than to the oxygen flowmeter as required by pt. There was no problem reported prior to or after the incident regarding the operation of either the oxygen or medical air flowmeters. Note: no model number, lot number or serial number were provided by initial reporter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617620-2012-00005 |
| MDR Report Key | 2621219 |
| Report Source | 00 |
| Date Received | 2012-06-12 |
| Date of Report | 2012-04-26 |
| Date of Event | 2012-04-17 |
| Report Date | 2012-04-01 |
| Date Reported to FDA | 2012-04-01 |
| Date Mfgr Received | 2012-05-07 |
| Date Added to Maude | 2012-10-10 |
| 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 Street | 1111 LAKESIDE DR. |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer Phone | 8478550500 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | FLOWMETER, OXYGEN |
| Product Code | CAX |
| Date Received | 2012-06-12 |
| Catalog Number | FM-15UA-OH |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-12 |