MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for INTEGRATED FLOW METER manufactured by Ohio Medical Llc.
[181415718]
Code blue called. Patient was being bag mask ventilated with 15l flow. Left side flowmeter stopped functioning abruptly while bagging the patient. Ambu bag was disconnected and connected to right side flowmeter and bagging resumed. Manufacturer response for o2 flow meter, integrated flow meter (per site reporter). Known issue with o ring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9769371 |
| MDR Report Key | 9769371 |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-12 |
| Report Date | 2020-02-17 |
| Date Reported to FDA | 2020-02-17 |
| 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 FLOW METER |
| Generic Name | FLOWMETER, NONBACK-PRESSURE COMPENSATED, BOURDON GAUGE |
| Product Code | CCN |
| Date Received | 2020-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |