MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-17 for SPIRIT 1200 SF 12944586 manufactured by Caire Inc..
[188211916]
A technician filled up the base unit (liberator 45) at a patient's house. The patient's wife called the technician 30 minutes after he left, saying the unit was empty again and needed to be refilled. On site, the technician was told that when filling the portable unit (spirit), it iced up and the valve did not close, so the base unit subsequently emptied. The technician checked both devices when refilling, but could not find the root cause for it icing up. The patient stated that he was in a hurry to fill up the portable, and it jammed. He tried to separate the portable unit from the base unit anyway, and the valve did not close anymore. The patient suffered a slight burn on the hand. The technician could not find any fault with the units, so they remained with the patient. The patient and his wife were both re-instructed on how to use the units, including before filling (temperature compensation and drying) and when the valve does not close. The patient has been supplied with oxygen since (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004972304-2020-00007 |
| MDR Report Key | 9716612 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-17 |
| Date of Event | 2019-08-05 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2016-08-23 |
| Date Added to Maude | 2020-02-17 |
| 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 | SPIRIT 1200 SF |
| Generic Name | UNIT, LIQUID OXYGEN, PORTABLE |
| Product Code | BYJ |
| Date Received | 2020-02-17 |
| Model Number | 12944586 |
| 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. Other | 2020-02-17 |