MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-12-21 for AQUABPLUS 2000 G02040107-US manufactured by Vivonic Gmbh.
[95667349]
A plant investigation is in progress. A supplemental medwatch report will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[95667350]
An installation logistics manager for vivonics reported that an aquabplus reverse osmosis machine underwent troubleshooting for a power failure. During machine repair, the manager had discovered that the power-switch terminal connections were melted. There was no report of heat damage to the machine? S other components. The area technical operations manager did report evidence of arching. The power-switch is being returned to the manufacturer for physical evaluation. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3010850471-2017-00003 |
MDR Report Key | 7139551 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2017-12-21 |
Date of Report | 2018-03-28 |
Date of Event | 2017-12-01 |
Date Mfgr Received | 2018-03-21 |
Date Added to Maude | 2017-12-21 |
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 | 3 |
Event Location | 3 |
Manufacturer Contact | THOMAS C. JOHNSON |
Manufacturer Street | 920 WINTER ST. |
Manufacturer City | WALTHAM MA 02451 |
Manufacturer Country | US |
Manufacturer Postal | 02451 |
Manufacturer Phone | 7816999499 |
Manufacturer G1 | VIVONIC GMBH |
Manufacturer Street | KURUFUERST-EPPSTEIN-RING 4 |
Manufacturer City | SAILAUF 63877 |
Manufacturer Country | GM |
Manufacturer Postal Code | 63877 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AQUABPLUS 2000 |
Generic Name | SUBSYSTEM, WATER PURIFICATION |
Product Code | FIP |
Date Received | 2017-12-21 |
Returned To Mfg | 2017-12-21 |
Model Number | AQUABPLUS 2000 |
Catalog Number | G02040107-US |
Lot Number | N/A |
Device Availability | R |
Device Age | MO |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | VIVONIC GMBH |
Manufacturer Address | KURUFUERST-EPPSTEIN-RING 4 SAILAUF 63877 GM 63877 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-12-21 |