MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-16 for LIFEGAS, SPEC GAS 5% CO2, 12% 02, BAL N2 6696 manufactured by Lifegas.
[19842181]
Data to be faxed to medwatch! Ordered calibration gas - e cylinder: 5% co2, 12% oxygen for blood gas analyzer. Rec'd cylinder with 2 labels: 5% co2, 12% oxygen; 10% co2, 12% oxygen. Reported mislabeled cylinder to (b)(4) at (b)(4), (b)(4), and called (b)(4) corporate office: notified (b)(4) at (b)(4). Ordered calibration gas: 5% co2, 12% oxygen. Rec'd "blood gas mixture - 4% co2, 16% oxygen. Reported wrong gas to (b)(4) at (b)(4), (b)(4), called (b)(4) corporate. Ordered calibration gas e cylinder: 21% oxygen, 79% nitrogen for pulmonary function testing. Rec'd e cylinder labeled 21% oxygen, 79% nitrogen with heliox (helium/oxygen) pin - indexed stem. Reported mislabeled cylinder to (b)(4) at (b)(4) at (b)(4) risk mgr. Diagnosis or reason for use: #1 & #2. Calibration gases for blood gas analyzer. Event reappeared after reintroduction: #1. & #2. No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016784 |
| MDR Report Key | 1766928 |
| Date Received | 2010-07-16 |
| Date of Report | 2010-07-16 |
| Date of Event | 2010-06-16 |
| Date Added to Maude | 2010-07-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEGAS, SPEC GAS 5% CO2, 12% 02, BAL N2 |
| Generic Name | LIFEGAS/LINDE, 5% CO2/12% 02/BAL N2/OTHER 10% CO2 |
| Product Code | ECX |
| Date Received | 2010-07-16 |
| Returned To Mfg | 2010-06-18 |
| Catalog Number | 6696 |
| Lot Number | 07195G08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFEGAS |
| Manufacturer Address | 7029 HUNTLEY RD COLUMBUS OH 43229 US 43229 |
| Brand Name | SPEC GAS 5% CO2, 12% 02, BAL N2 |
| Generic Name | 4% CO2/16%O2/BAL N2 |
| Product Code | ECX |
| Date Received | 2010-07-16 |
| Returned To Mfg | 2010-06-18 |
| Lot Number | 39099F605XB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | LIFEGAS |
| Manufacturer Address | 7029 HUNTLEY RD COLUMBUS OH 43229 US 43229 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-16 |