MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-10-15 for WATERS QUATTRO MICRO VB-QMICRO manufactured by Waters Corp.
[3083068]
During a service call, the customer reported to a waters field service engineer that on (b)(6), 2012, he had gotten four "strong static shocks" within a matter of seconds from the top cover of the quattro micro instrument that he did not think were static in nature. The customer said he was not injured and did not require medical attention.
Patient Sequence No: 1, Text Type: D, B5
[10431999]
A waters field service engineer (fse) inspected the instrument at the customer's site and did not find any faults with the device. He did not find any loose wires and the instrument was appropriately grounded. During his inspection of the instrument, the fse touched the cover and chassis and did not experience any electrical discharge. No previous similar events have been reported by the customer. And a follow-up call to the customer confirmed that no similar events have occurred since this event was reported. No issues were found with the device and no injury was reported. We consider this report complete. However, if additional information is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2012-00001 |
| MDR Report Key | 2796347 |
| Report Source | 00 |
| Date Received | 2012-10-15 |
| Date of Report | 2012-09-20 |
| Date of Event | 2012-09-17 |
| Date Mfgr Received | 2012-09-20 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2013-01-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PACHECO |
| Manufacturer Street | 34 MAPLE STREET |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal | 01757 |
| Manufacturer Phone | 5084822532 |
| Manufacturer G1 | WATERS TECHNOLOGIES IRELAND, LTD |
| Manufacturer Street | WEXFORD BUSINESS PARK, DRINAGH |
| Manufacturer City | WEXFORD |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATERS QUATTRO MICRO |
| Generic Name | DOP, MASS SPECTROMETER, CLINICAL USE |
| Product Code | DOP |
| Date Received | 2012-10-15 |
| Model Number | QUATTRO MICRO |
| Catalog Number | VB-QMICRO |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERS CORP |
| Manufacturer Address | 34 MAPLE STREET MILFORD MA 01757 US 01757 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-15 |