MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-07-13 for MAQUET CARDIOPULMONARY AG 70103.5075 manufactured by Maquet Cardiopulmonary Ag.
[6027564]
It was reported that customer stated belt slip alarm. No consequences to the patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[14207468]
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). Maquet cardiopulmonary is aware of similar complaints from this product. Similar products, showing similar malfunction have tested. A supplemental medwatch will be submitted after receiving new information.
Patient Sequence No: 1, Text Type: N, H10
[54771105]
Maquet cardiopulmonary is aware of similar complaints from this product. Similar products, showing similar malfunction, have tested. Customer stated the twin pump would display a belt slip message on screen prior to use. Service was called and evaluated the twin pump. Ran system at low and high rounds per minute with test tubing pack and no message or belt slip was displayed. Tested system to factory specifications. Tested ok. Thus failure cannot be confirmed. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations will be completed at this time.
Patient Sequence No: 1, Text Type: N, H10
[54771106]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2015-00800 |
| MDR Report Key | 4914867 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-07-13 |
| Date of Report | 2015-06-23 |
| Date of Event | 2015-06-22 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2015-07-22 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT |
| Manufacturer Country | GM |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAQUET CARDIOPULMONARY AG |
| Product Code | DPW |
| Date Received | 2015-07-13 |
| Model Number | 70103.5075 |
| Catalog Number | 70103.5075 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-13 |