MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-03-29 for WATERS QUATTRO LCZ SV-QLCZ manufactured by Waters Corp..
[2598203]
The waters service engineer reported that while servicing the instrument, the roughing pump began smoking. The pump was unplugged and a new pump was installed. No injuries occurred as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9710592]
The pump was returned to waters and is currently under eval. A supplemental report will be submitted upon completion of the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3000221947-2012-00001 |
| MDR Report Key | 2515163 |
| Report Source | 00 |
| Date Received | 2012-03-29 |
| Date of Report | 2012-03-29 |
| Date of Event | 2012-03-22 |
| Date Mfgr Received | 2012-03-22 |
| Device Manufacturer Date | 1998-09-01 |
| Date Added to Maude | 2012-09-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHLEEN MORAHAN |
| Manufacturer Street | 34 MAPLE ST. |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal | 01757 |
| Manufacturer Phone | 5084823574 |
| Manufacturer G1 | WATERS TECHNOLOGIES CORPORATION |
| Manufacturer Street | FLOATS RD. |
| Manufacturer City | WYTHEYSHAWE M239LZ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | M23 9LZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATERS QUATTRO LCZ |
| Generic Name | DOP, MASS SPECTROMETER, CLINICAL USE |
| Product Code | DOP |
| Date Received | 2012-03-29 |
| Returned To Mfg | 2012-03-27 |
| Model Number | QUATTRO LCZ |
| Catalog Number | SV-QLCZ |
| 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 ST. MILFORD MA 01757 US 01757 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-29 |