MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-04-18 for HUDSON/RCI 5620 * manufactured by Hudson Respiratory Care, Inc..
[22076383]
The pt was connected to a ventilator containing its own alarm. This ventilator was also connected to a remote alarm. This remote alarm was mounted on a shelf outside of the pt's room next to the door. The pt became disconnected from the ventilator. The ventilator alarm on the machine went off, but the remote alarm failed to alarm. 3/6/00 corrective maintenance was completed by the hosp biomedical engineering dept. They found the alarm to be in good working condition with no problems noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018707 |
| MDR Report Key | 274417 |
| Date Received | 2000-04-18 |
| Date of Report | 2000-04-18 |
| Date of Event | 2000-03-06 |
| Date Added to Maude | 2000-04-24 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON/RCI |
| Generic Name | ALARM/VENT PRESSURE |
| Product Code | CAP |
| Date Received | 2000-04-18 |
| Model Number | 5620 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 265618 |
| Manufacturer | HUDSON RESPIRATORY CARE, INC. |
| Manufacturer Address | 27711 DIAZ RD. TEMECULA CA 925899020 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-04-18 |