MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-03 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corporation.
[16416852]
The customer alleged the reservoir was leaking a mixture of cidex opa solution and water on the floor. No injuries were involved from the event. The fse assessed and repaired the unit on site. The unit is back in full operation.
Patient Sequence No: 1, Text Type: D, B5
[16423855]
The vendor evaluated at the customer site. The fse stated the customer reported; "eo1" errors, system at idle. The fse inspected the system and replaced the disinfect reservoir valve due to a fluid leak. The fse also performed a test cycle while monitoring the fluid level in the disinfect reservoir. There was not an increase in the fluid level after the cycle completed. At this time, the aer unit met the manufacturer's specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00162 |
| MDR Report Key | 1521020 |
| Report Source | 05 |
| Date Received | 2009-11-03 |
| Date of Report | 2009-10-13 |
| Date of Event | 2009-10-13 |
| Date Mfgr Received | 2009-10-13 |
| 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 WITH PRINTER |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-11-03 |
| 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 CORPORATION |
| Manufacturer Address | MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-03 |