MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-09-23 for SALTER LABS NASAL CANNULA 13300 UNK manufactured by Salter Labs.
[2235063]
On (b)(6) 2011, (b)(4) from distributor (b)(4), informed salter labs regarding a connection issue. While in use, nasal cannula disconnected from the oxygen outlet and pt did not receive oxygen. The nature of the medical intervention required is unk. No product has been returned to date. Current status of the pt is unk. Ongoing efforts are being made to find current status of pt. This is an interim report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921601-2011-00008 |
| MDR Report Key | 2269319 |
| Report Source | 08 |
| Date Received | 2011-09-23 |
| Date of Report | 2011-09-27 |
| Date Mfgr Received | 2011-09-01 |
| Date Added to Maude | 2011-09-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | COLLEEN MOYNA |
| Manufacturer Street | 100 WEST SYCAMORE RD. |
| Manufacturer City | ARVIN CA 93203 |
| Manufacturer Country | US |
| Manufacturer Postal | 93203 |
| Manufacturer Phone | 6618546862 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SALTER LABS NASAL CANNULA 13300 |
| Generic Name | NASAL CANNULA |
| Product Code | NFB |
| Date Received | 2011-09-23 |
| Model Number | UNK |
| Catalog Number | 13300 |
| Lot Number | 92208 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SALTER LABS |
| Manufacturer Address | ARVIN CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-23 |