MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-24 for AEROSTAR RS 0100 * manufactured by Stackhouse, Inc..
[58171]
During pentamidine treatment, metal shavings caused by failure of the motorized pulley escaped from the interior of the cart. No apparent injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011199 |
| MDR Report Key | 86383 |
| Date Received | 1997-04-24 |
| Date of Report | 1997-04-15 |
| Date of Event | 1997-04-08 |
| Date Added to Maude | 1997-04-28 |
| 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 |
| 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 | AEROSTAR RS 0100 |
| Generic Name | ENVIRONMENTAL CHAMBER |
| Product Code | LGM |
| Date Received | 1997-04-24 |
| Model Number | RS 0100 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | ECN 55928, CTU 63345 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 85574 |
| Manufacturer | STACKHOUSE, INC. |
| Manufacturer Address | 1100 BIRD CENTER DR PALM SPRINGS CA 90265 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-24 |