MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-07 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp..
[21747102]
Capital equipment evaluated at the customer site. The customer subsequently requested service. The field service engineer (fse) found the unit with a faulty power receptacle and circuit breaker. The fse replaced the parts and inspected the unit for water leaks; no leaks were found. The fse processed a successful wash and a wash/disinfect cycle, both with and without a scope. The unit conformed to the mfr's specifications. Result - circuit breaker.
Patient Sequence No: 1, Text Type: N, H10
[21788343]
The customer alleged the basin overflowed with water. The customer believed the water spilled onto the outlet. There were sparks and smoke coming from inside the unit, possibly due to a water overflow, the area where the plug connects to the unit was charred. The customer was not aware of any overflow since he was not present during the event. As a precaution, the healthcare worker, at the time, unplugged the power cord. The customer stated the prong to the power cord inside the unit broke. The customer stated no injuries were involved. A service was not requested. The customer will repair the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2009-00171 |
| MDR Report Key | 1556476 |
| Report Source | 05 |
| Date Received | 2009-12-07 |
| Date of Report | 2009-11-11 |
| Date of Event | 2009-11-11 |
| Date Mfgr Received | 2009-11-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GINNY STAMBERGER |
| Manufacturer Street | 33 TECH. 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 | 2009-12-07 |
| 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 | 2009-12-07 |