MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-01-29 for VAVD CONTROLLER 70102.4459 manufactured by Maquet Cardiopulmoary Ag.
[21329348]
On (b)(6) 2012 the ssu at maquet denmark reported that the vacuum was unstable, but the manometer was functioning on the vacuum controller (vavd) serial number (sn): (b)(4). The customer changed out the membrane but that did not resolve the issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21688882]
Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). Service report (b)(4) was generated for this event. It was determined that the unit was remounted in the incorrect way. The mounting was corrected and the device was tested per the service protocol. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-01032 |
| MDR Report Key | 4461733 |
| Report Source | 07 |
| Date Received | 2015-01-29 |
| Date of Report | 2012-02-09 |
| Date of Event | 2012-01-18 |
| Date Facility Aware | 2012-02-09 |
| Report Date | 2012-02-09 |
| Date Reported to Mfgr | 2012-02-09 |
| Date Mfgr Received | 2012-02-09 |
| 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 CARDIOPULMONARY 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 | 2012-01-19 |
| Model Number | 70102.4459 |
| Catalog Number | 70102.4459 |
| 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 |