MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for INTEGRATED FLOWMETER ATCP00842 manufactured by Ohio Medical Llc.
[181408965]
Noticed that oxygen was not flowing through flow meter when being set up for use on a patient. Manufacturer response for oxygen flow meter, integrated flowmeter (per site reporter). There is an issue with the o-ring on devices manufactured in 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9769332 |
| MDR Report Key | 9769332 |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-14 |
| Date of Event | 2019-10-22 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-02-28 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | INTEGRATED FLOWMETER |
| Generic Name | FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE |
| Product Code | CCN |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2019-11-15 |
| Model Number | ATCP00842 |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL LLC |
| Manufacturer Address | 1111 LAKESIDE DR GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |