MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-27 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp..
[1118440]
The customer alleged there was no disinfectant solution in the basin during the wash and disinfect cycle. The customer was certain the disinfectant solution was in the reservoir prior. The customer later stated cidex opa solution leaked outside the unit and onto the floor. There were no injuries involved. An asp field service engineer (fse) went to the facility, performed an assessement, and repaired the unit.
Patient Sequence No: 1, Text Type: D, B5
[8362899]
Equipment evaluated at the customer site. The fse arrived at the facility and found unit's reservoir was leaking around the heater element. The fse replaced the tank assembly and tested for leaks. The fse performed a test cycle then returned the unit to full operation. The fse reset the unit and had the customer enter the wash and disinfect cycle.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00160 |
| MDR Report Key | 1517153 |
| Report Source | 05 |
| Date Received | 2009-10-27 |
| Date of Report | 2009-09-29 |
| Date of Event | 2009-09-29 |
| Date Mfgr Received | 2009-09-29 |
| Date Added to Maude | 2009-11-09 |
| 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 DR. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | MINNTECH CORP. |
| 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 WITH PRINTER |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-10-27 |
| Model Number | NA |
| Catalog Number | 20301 |
| Lot Number | NA |
| ID Number | PART # : NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2009-10-27 |