MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-22 for CUSTOM ULTRASONICS SYSTEM 83+2 83+2 manufactured by Custom Ultrasonics Inc.
[1689217]
We received a phone call from mr (b)(6) on (b)(6) 2010, at (b)(6) indicating the operator left the system 83 on over the weekend and the disinfectant cidex became overheated in its reservoir. On opening the lid covering the reservoir containing the disinfectant, fumes were released into the face of the operator. Following the phone call from mr (b)(6), the service tech for that area was contacted by phone and dispatched to the hosp arriving on (b)(6) 2010 to evaluate the problem.
Patient Sequence No: 1, Text Type: D, B5
[8854767]
The service tech on arrival on (b)(6) 2010 reported that he found the system functioning normally and no overheating of the disinfectant reoccurred. Company records on the system were reviewed indicating the system was released from mfg on 12/23/1997 installed and in-serviced at the hosp jan 1998. The system's data base log indicates the system performed 23,925 cycles. As for the 23,925 cycles when multiplied by 85 functions per cycle, the system performed since 1998 2,033,626 component functions. On the basis of this info, the hosp issued an emergency purchase for a new system on (b)(6) 2010. The new system was installed and hosp personnel trained on (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523209-2010-00002 |
| MDR Report Key | 1883826 |
| Report Source | 06 |
| Date Received | 2010-10-22 |
| Date of Report | 2010-10-19 |
| Date of Event | 2010-10-04 |
| Date Mfgr Received | 2010-10-05 |
| Device Manufacturer Date | 1997-12-23 |
| Date Added to Maude | 2010-10-29 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BERND ASCHER, DIR |
| Manufacturer Street | 144 RAILROAD DR. |
| Manufacturer City | IVYLAND PA 18974 |
| Manufacturer Country | US |
| Manufacturer Postal | 18974 |
| Manufacturer Phone | 2153641796 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM ULTRASONICS |
| Generic Name | ENDOSCOPE WASHER/DISINFECTOR |
| Product Code | NVE |
| Date Received | 2010-10-22 |
| Model Number | SYSTEM 83+2 |
| Catalog Number | 83+2 |
| Lot Number | EQ#779 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CUSTOM ULTRASONICS INC |
| Manufacturer Address | 144 RAILROAD DR. IVYLAND PA 18974 US 18974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-22 |