| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER | AER EQUIPMENT | MINNTECH CORP. | NVE | NA | 20301 | NA | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-12-07 | 0 |
Patient 1
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 1
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.