MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-02-18 for VKMO 78000 70106.4525 manufactured by Maquet Cardiopulmonary Ag.
[18634922]
It was reported that during use, leakage from the air outlet of the device was observed. The device was exchanged immediately with no reported pt effect or delay in therapy. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18936519]
The product is not available for investigation. Maquet cardiopulmonary ag is aware of similar complaints showing a familiar malfunction and an internal process (b)(4) was initiated to determine the most probable root cause and to implement the appropriate corrective action. This data is being handled through a designated maquet cardiopulmonary tracking and trending process. Abbreviation mrb: material review board.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00091 |
| MDR Report Key | 4531280 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-18 |
| Date of Report | 2015-01-19 |
| Date of Event | 2015-01-19 |
| Date Mfgr Received | 2015-01-19 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-02-23 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VKMO 78000 |
| Generic Name | DTZ, DWE |
| Product Code | DTN |
| Date Received | 2015-02-18 |
| Model Number | VKMO 78000 |
| Catalog Number | 70106.4525 |
| Lot Number | 92143456 |
| Device Expiration Date | 2016-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-18 |