MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-07-27 for OXYGEN FLOWMETER UNK manufactured by Ohio Medical Corporation.
[2541797]
As reported to ohio medical corporation from report (b)(4):? On (b)(6) 2011, pt underwent biopsy of the left supraclavicular node with oxygen administered per simple mask, flowing at 5 l/min via the auxiliary flowmeter on the anesthesia delivery unit. During coagulation cautery using the esu, a flash fire occurred burning the mask, oxygen tubing and surgical drape. The fire was immediately extinguished; however, pt sustained first and second degree burns to the face and left shoulder.?
Patient Sequence No: 1, Text Type: D, B5
[9694547]
The auxiliary flowmeter on the anesthesia delivery unit was requested for eval but was not provided. The flowmeter part number and serial number was also requested but was not provided. Conclusion: we conclude that the ohio medical oxygen flowmeter was functioning properly and did not cause the flash fire associated with this adverse event. We conclude that all of the critical elements needed for an operating room fire were present as noted in this medwatch report and were the primary contributor to this adverse event. Lastly, our response is to educate and implement best practices as outlined by ecri? S guide to surgical fire prevention published in october 2009 to this facility and the key stakeholders, mainly operating room personnel. The ecri document also references other major societies that have also developed guidelines for the prevention of operating room fires, such as the aorn, apsf, an asa.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419185-2011-00001 |
| MDR Report Key | 2493932 |
| Report Source | 00 |
| Date Received | 2011-07-27 |
| Date of Report | 2011-07-25 |
| Date of Event | 2011-04-29 |
| Date Facility Aware | 2011-04-29 |
| Report Date | 2011-07-25 |
| Date Reported to Mfgr | 2011-05-13 |
| Date Added to Maude | 2012-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 1111 LAKESIDE DR. |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer Phone | 8478550500 |
| Manufacturer G1 | GE - DATEX OHMEDA |
| Manufacturer Street | 9900 INNOVATION DR. |
| Manufacturer City | WAWATECA WI 53226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN FLOWMETER |
| Generic Name | OXYGEN FLOWMETER |
| Product Code | CAX |
| Date Received | 2011-07-27 |
| Model Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL CORPORATION |
| Manufacturer Address | GURNEE IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-07-27 |