MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-05 for HELIUM CYLINDER UHP6K manufactured by Airgas Healthcare.
[94161300]
A tumor cryoablation device from healthtronics was tested in the (b)(6) hospital operating room just prior to use. Patient was anesthetized and prepared for procedure. The device uses argon gas to freeze the sterile probe, helium to warm it back up. After freezing, it was found that the procedure to warm the probe did not work. The procedure was canceled with no adverse effect on patient. The mfg. Rep returned the next day to troubleshoot the problem. It was confirmed that 3 helium tanks in the same lot did not warm the probe but instead, cooled it to around minus 7 degrees c. Testing with a helium tank from another lot number confirmed that the device operated properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073754 |
| MDR Report Key | 7086701 |
| Date Received | 2017-12-05 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-10-24 |
| Date Added to Maude | 2017-12-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HELIUM CYLINDER UHP6K |
| Generic Name | HELIUM CYLINDER UHP6K |
| Product Code | BSE |
| Date Received | 2017-12-05 |
| Returned To Mfg | 2017-11-29 |
| Lot Number | 166-400878318-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRGAS HEALTHCARE |
| Manufacturer Address | RIVERSIDE CA 92507 US 92507 |
| Brand Name | HELIUM CYLINDER UHP6K |
| Generic Name | HELIUM CYLINDER UHP6K |
| Product Code | BSE |
| Date Received | 2017-12-05 |
| Returned To Mfg | 2017-11-29 |
| Lot Number | 166-400878318-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | AIRGAS HEALTHCARE |
| Manufacturer Address | RIVERSIDE CA 92507 US 92507 |
| Brand Name | HELIUM CYLINDER UHP6K |
| Generic Name | HELIUM CYLINDER UHP6K |
| Product Code | BSE |
| Date Received | 2017-12-05 |
| Returned To Mfg | 2017-11-29 |
| Lot Number | 166-400878318-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | AIRGAS HEALTHCARE |
| Manufacturer Address | RIVERSIDE CA 92507 US 92507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-05 |