MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2015-01-29 for VAVD CONTROLLER 70103.5905 manufactured by Maquet Cardiopulmoary Ag.
[20123340]
On (b)(6) 2012 at the ssu at (b)(6) reported that the vacuum was unstable on the vacuum controller (vavd) serial number(sn): (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20185376]
(b)(4). Service report (b)(4) was generated for this event. The device was tested per the service protocol but the failure was not reproduced. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-01036 |
| MDR Report Key | 4461737 |
| Report Source | 00,01,06 |
| Date Received | 2015-01-29 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-02-16 |
| Date Facility Aware | 2012-07-17 |
| Report Date | 2012-07-17 |
| Date Reported to Mfgr | 2012-07-17 |
| Date Mfgr Received | 2012-07-17 |
| Date Added to Maude | 2015-03-05 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TINA EVANCHO |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097265 |
| Manufacturer G1 | MAQUET CARDIOPULMOARY AG |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT, 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAVD CONTROLLER |
| Generic Name | REGULATOR, VACUUM |
| Product Code | KDP |
| Date Received | 2015-01-29 |
| Returned To Mfg | 2012-07-16 |
| Model Number | 70103.5905 |
| Catalog Number | 70103.5905 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMOARY AG |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT, 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-29 |