MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-08 for STERIS SYSTEM 1 90A2 manufactured by *.
[1252213]
Two respiratory therapists were cleaning an olympus bronchoscope using the steris system 1 product. The machine indicated on the display panel, that it had completed cleaning the instrument. Rt# 1 opened the door to the device and was immediately exposed with caustic vapors to the face. Rt #2 standing behind rt #1 at the device, was also exposed to the vapor fumes and went into an asthmatic attack requiring emergent medical attention to alleviate the bronchoconstriction and was subsequently sent home from work and missed work days due to exposure. Rt# 1 was evaluated for chemical injury to the eyes and face and rec'd medical attention for chemical exposure. Following the medical eval, rt# 1 also missed work time due to incident exposure and the associated effects. The sys was locked and tagged out of service. Company's account manager was contacted and came to the facility in 2009 to attend a meeting related to the event. Dates of use: 2000 - 2009.
Patient Sequence No: 1, Text Type: D, B5
[6077350]
Two respiratory therapists were cleaning an olympus bronchoscope using the steris system 1 product. The machine indicated on the display panel, that it had completed cleaning the instrument. Rt# 1 opened the door to the device and was immediately exposed with caustic vapors to the face. Rt #2 standing behind rt #1 at the device, was also exposed to the vapor fumes and went into an asthmatic attack requiring emergent medical attention to alleviate the bronchoconstriction and was subsequently sent home from work and missed work days due to exposure. Rt# 1 was evaluated for chemical injury to the eyes and face and rec'd medical attention for chemical exposure. Following the medical eval, rt# 1 also missed work time due to incident exposure and the associated effects. The sys was locked and tagged out of service. Company's account manager was contacted and came to the facility in 2009 to attend a meeting related to the event. Dates of use: 2000 - 2009.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | MW5013875 |
| MDR Report Key | 1558289 |
| Date Received | 2009-12-08 |
| Date of Report | 2009-12-08 |
| Date of Event | 2009-08-07 |
| Date Added to Maude | 2009-12-15 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERIS SYSTEM 1 |
| Generic Name | STERIS |
| Product Code | FLF |
| Date Received | 2009-12-08 |
| Model Number | 90A2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | * |
| Manufacturer Address | 5960 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2009-12-08 |
| 2 | 0 | 1. Other; 2. Deathisabilit | 2009-12-08 |