MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-11-13 for NINGBO HENGFEUG PRESSURE GAUGE MFG CO. OXYGEN PRESSURE GAUGE NA manufactured by Ningbo Heugfeug Pressure Gauge Mfg.
[2727370]
(b)(4) has imported pressure gauges designed to be used on medical gas regulators that fell apart during normal use. High pressure oxygen leaks from faulty gauges that cause loss of gas. High pressure oxygen leaks can also be safety issues. (b)(4) claims gauges are approved for medical use. (b)(6) believes these gauges are not suitable for use with medical gas regulator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832475-2009-00001 |
| MDR Report Key | 2623150 |
| Report Source | 99 |
| Date Received | 2009-11-13 |
| Date Facility Aware | 2008-09-05 |
| Report Date | 2009-11-13 |
| Date Reported to FDA | 2009-11-13 |
| Date Added to Maude | 2012-06-25 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NINGBO HENGFEUG PRESSURE GAUGE MFG CO. |
| Generic Name | PRESSURE GAUGE 868-2610 |
| Product Code | CAP |
| Date Received | 2009-11-13 |
| Model Number | OXYGEN PRESSURE GAUGE |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NINGBO HEUGFEUG PRESSURE GAUGE MFG |
| Manufacturer Address | NO. 633 YONDIAN RD ANDANG TOWN, CIVI CITY, NIGGHO 315327 CH 315327 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2009-11-13 |