MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-01-03 for HELIOS H46T B-700847-00 manufactured by Caire Inc..
[188211223]
The unit has been returned for an evaluation. If any new information is discovered, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[188211224]
After the filling process at the patient's home, the unit iced up. Pangas retrieved the device for inspection in their repair centre. Their inspection revealed that the cable to the filling status display (gauge showing level of o2 in the tank) had burst and liquid oxygen had escaped from it. Because of continuous high pressure, lox flowed through the red tube which is directly connected to the display and caused the icing. Additional comments on 10th december 2019: the event happened during the filling process by the heimox operative in the technical room of a hospital. The tank was immediately taken out of service and therefore no patient was affected by the incident. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00055 |
| MDR Report Key | 9548784 |
| Report Source | FOREIGN |
| Date Received | 2020-01-03 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-11-20 |
| Date Mfgr Received | 2019-12-04 |
| Date Added to Maude | 2020-01-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NEAL MALOY |
| Manufacturer Street | 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 |
| Manufacturer City | BALL GROUND GA 30107 |
| Manufacturer Country | US |
| Manufacturer Postal | 30107 |
| Manufacturer Phone | 7707217700 |
| Manufacturer G1 | CAIRE INC. |
| Manufacturer Street | 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 |
| Manufacturer City | BALL GROUND GA 30107 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HELIOS H46T |
| Generic Name | UNIT, LIQUID OXYGEN, STATIONARY |
| Product Code | BYJ |
| Date Received | 2020-01-03 |
| Returned To Mfg | 2019-12-10 |
| Model Number | B-700847-00 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAIRE INC. |
| Manufacturer Address | 2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 BALL GROUND GA 30107 US 30107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |