MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-08-21 for STROLLER 10734067 manufactured by Caire Inc..
[117786793]
The unit has been returned for evaluation. A follow-up report will be submitted once an evaluation has been performed.
Patient Sequence No: 1, Text Type: N, H10
[117786794]
The patient has been using a portable lox product for approx. 1yr due to copd condition. Unit is filled every wednesday by vivisol and a general inspection made of the unit every time. On wed (b)(6) 2018 about 4 hours after filling, while the patient was in the restroom, the tube suddenly exploded near to the part applied to the nose and a fire began. The patient tore the tube away from her face immediately and doused with water. The patient's son, hearing her distress, broke down the door and tended to her while calling the emergency services. The patient suffered 2nd degree burns over the whole of her face as well as on the palm of her right hand. She spent a period of time in hospital to recover. Prognosis of doctors at the time was that she would make a full recovery, suffer no permanent damage and no skin grafts would be necessary.
Patient Sequence No: 1, Text Type: D, B5
[123719367]
The lady that was affected has now passed. They also found out that she was smoking during oxygen therapy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004972304-2018-00028 |
| MDR Report Key | 7802634 |
| Report Source | FOREIGN |
| Date Received | 2018-08-21 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-02-14 |
| Date Mfgr Received | 2018-07-24 |
| Date Added to Maude | 2018-08-21 |
| 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 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 | STROLLER |
| Generic Name | UNIT, LIQUID OXYGEN, PORTABLE |
| Product Code | BYJ |
| Date Received | 2018-08-21 |
| Returned To Mfg | 2018-07-23 |
| Model Number | 10734067 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-08-21 |