MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-20 for HELIOS H850 manufactured by Caire Inc..
[188213766]
The unit has not been returned for evaluation. If any new information is discovered, a followup report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[188213767]
This report was originally submitted on 08/10/2017, and is being resubmitted on 3/20/2020 as the original submission failed to go through. A patient with copd has a helios h46 from which he fills the portable unit. On (b)(6), the base unit was filled by the service driver. On (b)(6) the patient stated low o2 was being released from the portable unit. The bed was wet and the patient started to panic and he hit his head on the headboard and suffered a small bump. His wife and he tried several times on (b)(6) to make the unit work, but the oxygen situation did not change. The base unit was also not releasing oxygen, as its humidifier adapter was broken. The patient's wife took him to the hospital the following afternoon. There, the patient showed signs of hypoglycemia (probably because of the panic). His saturation was at 60% and raised to 80% with the oxygen therapy in the hospital. The collection of the unit and an examination was conducted on (b)(6) by the customer. The portable unit was all right and no damage was found. The humidifier adapter was broken on the base unit causing the oxygen to not be able to flow from the unit. The patient was discharged from the hospital on (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2017-00020 |
| MDR Report Key | 9861852 |
| Report Source | FOREIGN |
| Date Received | 2020-03-20 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-07-11 |
| Date Added to Maude | 2020-03-20 |
| 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 H850 |
| Generic Name | UNIT, LIQUID OXYGEN, PORTABLE |
| Product Code | BYJ |
| Date Received | 2020-03-20 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Hospitalization | 2020-03-20 |