MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-10-08 for PREPMATE 1000 799-04800-00 manufactured by Tripath Imaging.
[17395099]
In tracking complaints over the past 7 years, it was noticed that certain prepmate vial processors exhibited smoking, sparkling or small, self extinguishing flames on one small circuit board internal to the instrument. This occurs most frequently in large volume labs that process high numbers of samples and clean the instrument more aggressively. There have been no injuries, deaths or damage associated with these occurrences. While bd-tripath has attempted to prevent these events by reminding users of the cleaning instructions in the labeling and installing coated boards that self extinguish any flames, this trend has increased in the last 30 days (5 instances). The problem stems from the user spraying the machine with disinfectant solution rather than wiping it with a cloth or sprayed with the disinfectant. The excessive liquid or spray has come in contact with the circuit board and caused corrosion. Over time the board becomes corroded enough to malfunction resulting in an electrical short and sparks, smoke or small flames. User cleaning error.
Patient Sequence No: 1, Text Type: D, B5
[17677894]
Over zealous application of the disinfectant cleaning solutions is causing circuit boards in the prepmate to corrode and then malfunction. Additional studies have been initiated to improve the design of the prepmate. Decision to file was based on the potential for users to be injured while using the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1062336-2007-00003 |
| MDR Report Key | 925304 |
| Report Source | 05 |
| Date Received | 2007-10-08 |
| Date of Report | 2007-10-05 |
| Date of Event | 2007-09-10 |
| Date Mfgr Received | 2007-09-10 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2007-11-21 |
| 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 | KENNETH EDDS, SR. DIRECTOR |
| Manufacturer Street | 4025 STIRRUP CREEK DRIVE |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9192067140 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREPMATE |
| Generic Name | CERVICAL CYTOLOGY VIAL PROCESSOR |
| Product Code | LEA |
| Date Received | 2007-10-08 |
| Model Number | 1000 |
| Catalog Number | 799-04800-00 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 921405 |
| Manufacturer | TRIPATH IMAGING |
| Manufacturer Address | 780 PLANTATION DR. BURLINGTON NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-08 |