MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-07 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR AER387 manufactured by Minntech Corp..
[1177743]
The customer alleged a cidex brand solution leak. During a wash and disinfect cycle, the unit leaked cidex onto the floor. The customer could not tell where the leak originated. There were no injuries involved associated with the cidex leak. The customer cleaned up the solution and checked to make sure the cycle completed prior to the system leak. The customer then performed a wash and disinfect cycle with water to determine where the leak originated. At this time, no info is received from the customer on the status of the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2009-00153 |
| MDR Report Key | 1506329 |
| Report Source | 05 |
| Date Received | 2009-10-07 |
| Date of Report | 2009-09-10 |
| Date of Event | 2009-09-10 |
| Date Mfgr Received | 2009-09-10 |
| Date Added to Maude | 2009-11-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | GINNY STAMBERGER |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | MINNTECH CORPORATION |
| Manufacturer Street | 14605 28TH AVE. NORTH |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASP AUTOMATIC ENDOSCOPE REPROCESSOR |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-10-07 |
| Model Number | NA |
| Catalog Number | AER387 |
| Lot Number | NA |
| ID Number | PART#: NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINNTECH CORP. |
| Manufacturer Address | MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-07 |