MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-01-13 for OXYGEN MASK HIGH CONCENTR. 7FT. TUBING REBREATHER ADULT 25/CA 001123 manufactured by Smiths Medical Asd, Inc..
[64776814]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[64776815]
It was reported immediately after opening the oxygen mask high concentration 7 foot tubing rebreather the user found the tubing tip was 'firm' and it was difficult to connect to the oxygen flowmeter nipple. The user also reports the patient was 'in shock', underwent resuscitation and temporarily recovered. The rebreather oxygen mask tubing disconnected 3 to 4 times from the oxygen flowmeter during the two hours it was used. It was further reported the patient expired and the doctor stated the cause of death was not due to the disconnection of the oxygen tube to the flowmeter, however 'the association was not entirely denied'.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2017-00167 |
| MDR Report Key | 6250556 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-13 |
| Date of Report | 2016-12-19 |
| Date Mfgr Received | 2016-12-19 |
| Date Added to Maude | 2017-01-13 |
| 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 | MS. LISA PERZ |
| Manufacturer Street | SMITHS MEDICAL ASD, INC. 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 9124 POLK LANE SUITE 101 |
| Manufacturer City | OLIVE BRANCH MS 38654 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38654 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN MASK HIGH CONCENTR. 7FT. TUBING REBREATHER ADULT 25/CA |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2017-01-13 |
| Catalog Number | 001123 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-01-13 |