MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-07-22 for NITROGEN, COMPRESSED NF manufactured by .
[20513217]
On 06/17/10, we were notified by our distributor, (b) (4), that (b) (6) hospital reported that a nitrogen cylinder, which was being used to power surgical equipment, had given off an odor in one of its operating rooms, where a procedure was in progress. The odor reportedly caused the doctors and nurses present to feel nauseous and complaining of burning eyes. The odor was described as a chlorine/ hydrocarbon-like smell, similar to a cleaning agent. (b) (6) reported this to (b) (4) in (b) (4), a distributor of airgas south. Then (b) (4) reported the event to airgas south in (b) (4) on the same day. The individuals who had smelled the gas in the operating room reportedly immediately felt sick, but reportedly recovered. The staff was able to successfully complete the procedure on the pt and the pt reportedly was doing well. Airgas south initiated an immediate investigation. (b) (6) also submitted a report to medwatch. Therapy date: (b) (6)2010.
Patient Sequence No: 1, Text Type: D, B5
[20707789]
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Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022618-2010-00001 |
| MDR Report Key | 1768430 |
| Report Source | 07 |
| Date Received | 2010-07-22 |
| Date of Report | 2010-06-30 |
| Date of Event | 2010-06-17 |
| Date Mfgr Received | 2010-06-17 |
| Date Added to Maude | 2010-07-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 125 TOWNPARK DR. STE 400 |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 6789942423 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NITROGEN, COMPRESSED NF |
| Generic Name | NA |
| Product Code | ECX |
| Date Received | 2010-07-22 |
| Lot Number | WC01X153A |
| Device Expiration Date | 2015-06-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-07-22 |