MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-02-08 for STROLLER 11933113 manufactured by Caire Inc..
[138445907]
Unit has been returned for evaluation by manufacturer. If any new information is discovered, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[138445908]
Patient reported escape of liquid oxygen from one or both units. Client was unable to reach their supplier (our customer) on the emergency phone line, so called the fire service. Ambulance and police were also called to the scene. The fire service evacuated the building and concluded that there was a fault with a unit. After their own internal inspection of the units, the customer suspects that the portable unit simply iced up during filling due to user error. Update 15th january 2019: internal report from customer (b)(6). Liberator tank was iced up after filling up the stroller portable. Patient couldn't reach their supplier on a saturday so called the emergency services instead. Police, fire and ambulance all attended the scene. Fire service evacuated the building and took the tank outside. They identified a fault with the tank but no further details. A child was taken to hospital. Client contacted the customer after the event and stated that all in the building were in danger of their lives. Update 17th january 2019: the police confirmed that they took no official measures in relation to the incident and that therefore no written record of the incident was made update 5th february 2019: report from fire service of 2nd february. The unit was in the living room, the unit had already iced up significantly at the valve where the oxygen had escaped. The fire officers could not stop the escape of gas, so they took the unit outside to let the rest of the gas out in a controlled manner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2019-00003 |
| MDR Report Key | 8323257 |
| Report Source | FOREIGN |
| Date Received | 2019-02-08 |
| Date of Report | 2019-04-03 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2019-01-09 |
| Date Added to Maude | 2019-02-08 |
| 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 | 2019-02-08 |
| Returned To Mfg | 2019-01-09 |
| Model Number | 11933113 |
| 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 | 2019-02-08 |