MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-18 for ADVANCED STERILIZATION PRODUCTS 387P - 2 NA manufactured by Johnson And Johnson.
[1451473]
While cleaning an endoscope, the tech noted the device (asp automatic endoscope reprocessor) to be running hot. She called the charge nurse to the unit and when she felt the lid, it was extremely hot. She stopped the cleaning cycle and called biomed. Biomed came into the room and lifted up the lid and steam came up and when he checked the solution temp, it was around 107 degrees. The fumes from the cidex opa went into the air and caused some eye irritation/light headedness. Staff removed from area. Device was taken out of service and contained in a secure area. The asp company was called and a message was left for advanced sterilization products rep. A return call from the company came later on the day of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014048 |
| MDR Report Key | 1564735 |
| Date Received | 2009-12-18 |
| Date of Report | 2009-12-18 |
| Date of Event | 2009-12-17 |
| Date Added to Maude | 2009-12-28 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED STERILIZATION PRODUCTS |
| Generic Name | AUTOMATIC ENDOSCOPE REPROCESSOR |
| Product Code | NVE |
| Date Received | 2009-12-18 |
| Model Number | 387P - 2 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON AND JOHNSON |
| Manufacturer Address | 33 TECHNOLOGY DR. IRVINE CA 92616982 US 92616 9824 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-18 |