MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-17 for CYLINDER, COMPRESSED GAS, AND VALVE manufactured by .
[73063970]
Patient Sequence No: 1, Text Type: N, H10
[73063971]
Helium tank malfunction, no helium in tank although red full tag was on tank. Physician chose to close patient and abort surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6498269 |
| MDR Report Key | 6498269 |
| Date Received | 2017-04-17 |
| Date of Report | 2017-03-10 |
| Date of Event | 2016-12-21 |
| Report Date | 2017-01-03 |
| Date Reported to FDA | 2017-01-03 |
| Date Reported to Mfgr | 2017-01-03 |
| Date Added to Maude | 2017-04-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Generic Name | CYLINDER, COMPRESSED GAS, AND VALVE |
| Product Code | ECX |
| Date Received | 2017-04-17 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-17 |