MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-28 for STROLLER 14909784 manufactured by Caire Inc..
[146279070]
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
[146279071]
The patient was filling the portable lox unit from the base unit. The fill nozzle iced up to the extent that the portable unit could no longer be separated from the base unit, and liquid oxygen escaped. In attempting to get the portable unit loose from the base unit, the patient's toes came into contact with liquid oxygen. The patient was taken to hospital and as far as the customer knows she is still an in-patient there. Customer confirms that the patient has been using lox products since (b)(6) 2018 and was trained in proper filling procedures. Whether an error in operation occurred here is not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00033 |
| MDR Report Key | 8647371 |
| Report Source | FOREIGN |
| Date Received | 2019-05-28 |
| Date of Report | 2019-08-08 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-04-29 |
| Date Added to Maude | 2019-05-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2019-05-28 |
| Returned To Mfg | 2019-05-10 |
| Model Number | 14909784 |
| 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 | 1. Death; 2. Hospitalization | 2019-05-28 |