MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-03 for AMVEX INTEGRATED FLOWMETER FI-C15UO-DD-B manufactured by Amvex Corporation.
[32591215]
An occurence was reported to mfg amvex corporation on (b)(6) 2015 regarding an incident that occured on (b)(6) 2015 in which fm dial was positioned between 10 and 15 and no oxygen was delivered. Device functioned as designed. When dialed between numbers, oxygen flow will not be achieved. User facility was contacted via telephone and user error was confirmed. While no serious injury was reported to the manufacturer this event is being reported due to the potential for serious injury should a user not heed to the warning listed "warning: there is no flow between settings. " listed in important safety instructions on page 2 on product manual, and stated on page 3 under intended use. Device operating as designed. User error.
Patient Sequence No: 1, Text Type: N, H10
[32591216]
An intubated patient was being transferred to a different room in the unit. During the transfer, the patient was being "bagged" via ambu bag. When the ambu bag was connected to the wall in the new room, the respiratory therapist turned the oxygen flow dial to a position she thought was 15 liters. While looking at the reservoir bag attached to the ambu, she noticed it was not inflating. They immediately moved the tubing to another oxygen delivery nozzle in the room and turned it up to 15 liters with immediate inflation of the bag indicating appropriate delivery. Upon investigation, the nurse identified that the dial was positioned between the 10 and the 15 and was delivering no oxygen. This patient, due to the delay in therapy, suffered a severe drop in her oxygen saturation and took hours and creative ventilator management to recover.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617620-2015-00001 |
| MDR Report Key | 5262975 |
| Report Source | USER FACILITY |
| Date Received | 2015-12-03 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-10-15 |
| Date Mfgr Received | 2015-11-02 |
| Date Added to Maude | 2015-12-03 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHARMAINE PENNEY |
| Manufacturer Street | 25B EAST PIERCE ST RICHMOND HILL |
| Manufacturer City | TORONTO L4B 2M9 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4B 2M9 |
| Manufacturer Phone | 7647736 |
| Manufacturer G1 | AMVEX CORPORATION |
| Manufacturer Street | 25B EAST PIERCE ST RICHMOND HILL |
| Manufacturer City | TORONTO L4B 2M9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4B 2M9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMVEX INTEGRATED FLOWMETER |
| Generic Name | INTEGRATED FLOWMETER |
| Product Code | CCN |
| Date Received | 2015-12-03 |
| Model Number | FI-C15UO-DD-B |
| Catalog Number | FI-C15UO-DD-B |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMVEX CORPORATION |
| Manufacturer Address | 25B EAST PIERCE ST RICHMOND HILL ONTARIO L4B 2M9 CA L4B 2M9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-03 |