MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-17 for DIAL FLOWMETER 7MFA manufactured by Precision Medical.
[2264704]
Flowmeter does not provide oxygen when between the numbers of the dial. At some point, the bed wheel kinked the oxygen tubing, causing a hissing sound. An unidentified person likely changed the dial setting to between the numbers to prevent noise, unaware it stopped oxygen flow. Other flowmeters allow flow between the settings in a continuous flow increase, but these flowmeters only provide oxygen when "clicked" into a specific number, causing confusion and no oxygen to the patient if not set correctly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2222469 |
| MDR Report Key | 2222469 |
| Date Received | 2011-08-17 |
| Date of Report | 2011-08-16 |
| Date of Event | 2011-07-22 |
| Report Date | 2011-08-16 |
| Date Reported to FDA | 2011-08-17 |
| Date Added to Maude | 2011-08-25 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAL FLOWMETER |
| Generic Name | FLOWMETER |
| Product Code | CAX |
| Date Received | 2011-08-17 |
| Model Number | 7MFA |
| Catalog Number | 7MFA |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL |
| Manufacturer Address | 300 HELD DRIVE NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-17 |