MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-12-05 for WATERS QUATTRO PREMIER M94630DC1 manufactured by Waters Corp..
[2951313]
The user reported that they found the system shut down when they arrived in the morning. The customer said the rotary interlock box was burned and that there were burn marks on the floor.
Patient Sequence No: 1, Text Type: D, B5
[10331378]
Based on information reported by the customer, the instrument was not functioning when they arrived in the morning. There were burn marks on the floor, but the lab sprinklers did not go off. No injuries were reported. The rotary interlock switchbox from the device was returned to waters. A supplemental mdr will be sent when the results of the investigation of the returned component are completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2012-00003 |
| MDR Report Key | 2862172 |
| Report Source | 01,06 |
| Date Received | 2012-12-05 |
| Date of Report | 2012-11-09 |
| Date of Event | 2012-11-09 |
| Date Mfgr Received | 2012-11-09 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2013-03-12 |
| 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 | 3 |
| Manufacturer Contact | MICHAEL PACHECO |
| Manufacturer Street | 34 MAPLE ST. |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATERS QUATTRO PREMIER |
| Generic Name | DOP MASS SPECTROMETER, CLINICAL USE |
| Product Code | DOP |
| Date Received | 2012-12-05 |
| Returned To Mfg | 2012-11-30 |
| Model Number | QUATTRO PREMIER |
| Catalog Number | M94630DC1 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERS CORP. |
| Manufacturer Address | 34 MAPLE ST. MILFORD MA 01757 US 01757 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-05 |