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 70102.5905 manufactured by Maquet Cardiopulmoary Ag.
[19308510]
On (b)(6) 2011 (b)(6) reported that the actual pressure on the vacuum controller (vavd) serial number(sn): (b)(4) when measured by a pressure gauge fluctuated between +10mmhg and -10mmhg of the set pressure after switching the device on and then off. The membrane was replaced but that did not resolve the issue. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19539483]
Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). Per service order (b)(4) the membrane, vacuum chamber, maintenance kit, cylinder and cylinder sealing were replaced. Maintenance was performed according to the service protocol. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-01031 |
| MDR Report Key | 4461708 |
| Report Source | 07 |
| Date Received | 2015-01-29 |
| Date of Report | 2011-10-26 |
| Date of Event | 2011-10-26 |
| Date Facility Aware | 2011-10-26 |
| Report Date | 2011-10-26 |
| Date Reported to Mfgr | 2011-10-26 |
| Date Mfgr Received | 2011-10-26 |
| 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 |
| Remedial Action | RP |
| 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 | 2011-10-27 |
| Model Number | 70102.5905 |
| Catalog Number | 70102.5905 |
| 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 |