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 2017-10-05 for AQUABPLUS 2500 G02040108-US manufactured by Vivonic Gmbh.
[89478550]
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
[89478591]
A user facility biomedical technician (biomed) reported that an aquabplus reverse osmosis machine and the connection line 24v was found to have burn damage. There was no report of any other heat or burn damage to the machine? S components. No parts have been made available to be returned to the manufacturer for evaluation. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010850471-2017-00002 |
| MDR Report Key | 6917064 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-05 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-05-29 |
| Date Mfgr Received | 2017-11-16 |
| Date Added to Maude | 2017-10-05 |
| 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 | BIOMEDICAL ENGINEER |
| 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 2500 |
| Generic Name | SUBSYSTEM, WATER PURIFICATION |
| Product Code | FIP |
| Date Received | 2017-10-05 |
| Catalog Number | G02040108-US |
| Operator | BIOMEDICAL ENGINEER |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-05 |