MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-20 for AMVEX FM-04UO manufactured by .
[2540187]
Title: xxxxx. Event desc: infant on. 03l of wall 02 via a pediatric flow meter, with a spo2 of 99-100%. Weaned to 21% o2 - wall o2 turned off. Discovered a mild - flow through nasal cannula while in off position. When placed in 21%, without nasal cannula, spo2 = 65%. Pt was immediately placed back on o2 to recover to spo2. Respiratory therapy notified; pediatric flow meter removed and replacement out in. What was the original intended procedure? Deliver pt o2. Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
[9711764]
Amvex is waiting for the device to come back for eval. This device is not classified as paediatrics or neonatal flowmeter. On (b)(4) 2011, amvex customer service rep has spoken to (b)(6) on the phone and notified her to return the device to amvex for eval. A f/u email with instructions was sent to (b)(6) on the same day of (b)(6) 2011. On (b)(4) 2011, another email was sent to (b)(6) to f/u if the product is returned. The product is not returned yet.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617620-2011-00002 |
| MDR Report Key | 2453696 |
| Report Source | 05 |
| Date Received | 2012-01-20 |
| Date of Report | 2011-10-19 |
| Date of Event | 2011-10-02 |
| Report Date | 2011-10-01 |
| Date Reported to FDA | 2011-11-01 |
| Date Mfgr Received | 2011-12-01 |
| Device Manufacturer Date | 2010-04-07 |
| Date Added to Maude | 2012-08-08 |
| 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 | 0 |
| Manufacturer Street | 25B EAST PEARCE STREET |
| Manufacturer City | RICHMOND HILL, ONTARIO L4B 2M9 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4B 2M9 |
| Manufacturer Phone | 7647736 |
| Single Use | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMVEX |
| Generic Name | FLOWMETER, PEDIATRIC, O2 |
| Product Code | CAX |
| Date Received | 2012-01-20 |
| Model Number | FM-04UO |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-20 |