MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-16 for LANEY LT500 manufactured by Laney Technical.
[1256124]
Laney box did not function -send alarm- when tubing disconnected from ventilator. Rt happened to be walking by when ventilator alarm sounded. Laney box removed from the room. No adverse effect to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013700 |
| MDR Report Key | 1546297 |
| Date Received | 2009-09-16 |
| Date of Report | 2009-09-16 |
| Date of Event | 2009-08-11 |
| Date Added to Maude | 2009-12-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LANEY |
| Generic Name | LANEY BOX -ALARM- |
| Product Code | DSM |
| Date Received | 2009-09-16 |
| Model Number | LT500 |
| ID Number | ~ AGE 2 YRS. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LANEY TECHNICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-16 |