MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-09 for AMVEX FLOWMETER manufactured by Ohio Medical.
[99899326]
Hospice patient was placed on 70 percent fio2 via t-piece delivered at 15 l/min. Oxygen tubing was witnessed by nursing staff to pop off at venturi connection. This was replaced by staff. Patient was found with t-piece on chest and o2 disconnected from flow meter. Indicator ball noted to be floating at top of meter. Patient expired. Nurse, upon finding patient, reconnected oxygen and during assessment of patient for any vital signs, tubing again dislodged from flow meter. Flow meter was tested by biomedical department and found it to be delivering oxygen outside of manufacturer specification. At 15 l, the flow meter was delivering 20. 14 l/min. Utilizing a different oxygen set up mirroring the patient set up in a controlled biomed environment, tubing connected to this flow meter again popped off at the venturi connection at 10 minutes of flow, and once replaced, regulator ball was witnessed to drift to the top of regulator. Once tubing replaced, the system popped off the tubing again at 20 minutes of flow. Ref mfr # 1419185-2018-00001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7263180 |
| MDR Report Key | 7263180 |
| Date Received | 2018-02-09 |
| Date of Report | 2018-02-02 |
| Date of Event | 2018-01-29 |
| Date Facility Aware | 2018-01-29 |
| Report Date | 2018-02-02 |
| Date Reported to FDA | 2018-02-02 |
| Date Reported to Mfgr | 2018-02-02 |
| Date Added to Maude | 2018-02-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AMVEX FLOWMETER |
| Generic Name | AMVEX FLOWMETER |
| Product Code | CCN |
| Date Received | 2018-02-09 |
| Lot Number | FMAC 2946960 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL |
| Manufacturer Address | 1111 LAKESIDE DRIVE GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-02-09 |