MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-28 for HANS RUDOLPH 8411A 112830 manufactured by Hans Rudolph, Inc..
[17114693]
Hospital staff specifically requested subject device to be delivered to them for use on the above pt, our rep. Complied. Hospital reports increased resistance to ventilation related to subject device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 39748-1995-00001 |
| MDR Report Key | 22091 |
| Date Received | 1995-03-28 |
| Date of Report | 1995-03-10 |
| Date of Event | 1995-01-27 |
| Date Facility Aware | 1995-02-27 |
| Report Date | 1995-03-10 |
| Date Reported to FDA | 1995-03-10 |
| Date Reported to Mfgr | 1995-03-10 |
| Date Added to Maude | 1995-06-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | HANS RUDOLPH |
| Generic Name | NON HEATED PNEUMOTACH |
| Product Code | JAX |
| Date Received | 1995-03-28 |
| Model Number | 8411A |
| Catalog Number | 112830 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22180 |
| Manufacturer | HANS RUDOLPH, INC. |
| Manufacturer Address | 7200 WYANDOTTE KANSAS CITY MO 64114 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 1995-03-28 |