MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-14 for WATERS QUATTRO MICRO VB-QMICRO manufactured by Waters Corp.
[17894501]
The customer reported a vacuum roughing pump "caught on fire (wasn't total fire but a lot of smoke). " the pump was unplugged. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[17979294]
The vacuum roughing pump is an external component to the mass spectrometer (ms) instrument. The pump is connected to the ms instrument via tubing. A preliminary visual inspection of the pump revealed that the damage was limited to the components inside the pump's electronics box. Additionally, black residue was found on the outside of the pump. Photographs were taken. The pump was removed from the customer's site and a new pump was installed. The pump has been returned to the vendor in the (b)(4) for evaluation. Waters is awaiting the results of the vendor's investigation. A supplemental report will be provided upon completion of the evaluation. "initial use of device" was checked. The ms instrument is capital equipment and was new when installed at the customer site.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2010-00002 |
| MDR Report Key | 1701186 |
| Report Source | 05 |
| Date Received | 2010-05-14 |
| Date of Report | 2010-05-13 |
| Date of Event | 2010-04-26 |
| Date Mfgr Received | 2010-04-26 |
| Date Added to Maude | 2011-03-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATERS QUATTRO MICRO |
| Generic Name | DOP, MASS SPECTROMETER, CLINICAL USE |
| Product Code | DOP |
| Date Received | 2010-05-14 |
| Returned To Mfg | 2010-04-30 |
| Model Number | QUATTRO MICRO |
| Catalog Number | VB-QMICRO |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2010-05-14 |