MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-20 for SALTER LABS OXYGEN TUBING 2025G manufactured by Salter Labs.
[102996124]
(b)(4). Initial report found during review of maude database. Per initial report, no malfunction. Lot number not provided; initial reporter information not provided, further investigation is not possible. Not previously reported to salter labs. This is the initial and final report.
Patient Sequence No: 0, Text Type: N, H10
[102996125]
Companion report to (b)(4). The patient was being assisted to the bathroom by an aide who tripped over the tubing, causing the patient to also fall. Injury reported (hip fracture). Patient was treated at hospital for pain only per family request, and subsequently died. No device malfunction reported.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | 3000219639-2018-00003 |
| MDR Report Key | 7355976 |
| Date Received | 2018-03-20 |
| Date of Report | 2018-03-21 |
| Date of Event | 2017-06-26 |
| Date Mfgr Received | 2018-02-28 |
| Date Added to Maude | 2018-03-20 |
| 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 | MARA CALER |
| Manufacturer Street | 236 CAMINO VIDA ROBLE |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 7607957094 |
| Manufacturer G1 | SALTER LABS |
| Manufacturer Street | 2365 CAMINO VIDA ROBLE |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SALTER LABS OXYGEN TUBING |
| Generic Name | OXYGEN TUBING |
| Product Code | BYX |
| Date Received | 2018-03-20 |
| Model Number | 2025G |
| Catalog Number | 2025G |
| Lot Number | N/A |
| Operator | HOME HEALTH AIDE |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SALTER LABS |
| Manufacturer Address | 2365 CAMINO VIDA ROBLE CARLSBAD CA 92011 US 92011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Death | 2018-03-20 |