MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-18 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp..
[1276462]
The customer alleged the unit was leaking fluid around the heater on the reservoir. Subsequently, the customer stated the unit leaked cidex opa solution onto the floor. No injuries or adverse effects were involved. The fse assessed and repaired the unit on site. It is in operation.
Patient Sequence No: 1, Text Type: D, B5
[8495707]
Capital equipment evaluated at the customer site. The field service engineer (fse) discovered the tank assembly leaking. The fse replaced the tank assembly. The fse tested the unit and confirmed no leaks were present. The unit operated within the mfr's specs and operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2150060-2009-00179 |
| MDR Report Key | 1576994 |
| Report Source | 05 |
| Date Received | 2009-12-18 |
| Date of Report | 2009-11-30 |
| Date of Event | 2009-11-30 |
| Date Mfgr Received | 2009-11-30 |
| Date Added to Maude | 2010-03-05 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2009-12-18 |
| 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 | 2009-12-18 |