MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-31 for UNK manufactured by Mclan Engineering Co..
[43155]
Ventilator disconnect alarm activited, however external alarm to light outside pt room and to nursing station did not alarm. Found cable to external alarm to be severed or separated from plug. Pt coded and survived with decreased mental status. Pt expired 12/23/96 after massive gi bleed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 65270 |
| MDR Report Key | 65270 |
| Date Received | 1996-12-31 |
| Date of Report | 1996-12-24 |
| Date of Event | 1996-12-20 |
| Date Facility Aware | 1996-12-23 |
| Report Date | 1996-12-24 |
| Date Reported to FDA | 1996-12-26 |
| Date Reported to Mfgr | 1996-12-26 |
| Date Added to Maude | 1997-01-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | CABLE |
| Product Code | MOD |
| Date Received | 1996-12-31 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 65366 |
| Manufacturer | MCLAN ENGINEERING CO. |
| Manufacturer Address | 1339 WOODDELL DR JACKSON MS 39212 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1996-12-31 |