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 AER387 manufactured by Minntech Corp..
[15008985]
The customer alleged the unit was leaking cidex opa solution. The customer stated the hose attached to the y-connector at the top of the basin was dripping fluid onto the floor. There were no injuries reported. The customer later stated the leak was due to a crack in the reservoir most likely because of its age (wear and tear) and eventually needed replacing. The customer replaced the cracked reservoir and resolved the issue. No service was requested. The customer stated the unit is in full operation.
Patient Sequence No: 1, Text Type: D, B5
[15525388]
Equipment evaluated at the customer site. The customer replaced the cracked reservoir and returned the unit to full operation. The customer repaired the unit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00161 |
| MDR Report Key | 1517154 |
| Report Source | 05 |
| Date Received | 2009-10-27 |
| Date of Report | 2009-09-30 |
| Date of Event | 2009-09-30 |
| Date Mfgr Received | 2009-09-30 |
| Date Added to Maude | 2009-11-03 |
| 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 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 |
| Generic Name | AER EQUIPMENT |
| Product Code | NVE |
| Date Received | 2009-10-27 |
| 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 | 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 |