MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,06 report with the FDA on 2015-05-22 for MAQUET CARDIOPULMONARY AG 70102.8580 manufactured by Maquet Cardiopulmonary Ag.
[5925088]
It was reported that customer stated the single pump would display an intermittent belt slip error that progressively got worse over time. Pump is used in a teaching class and not on any patients. Pump to be sent to the national repair center in (b)(4) for service. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13413933]
(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
| Report Number | 8010762-2015-00662 |
| MDR Report Key | 4798447 |
| Report Source | 02,06 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-05-18 |
| Date of Event | 2015-05-18 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2015-06-19 |
| 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 | 0 |
| Event Location | 0 |
| 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 | 2015-05-22 |
| Model Number | 70102.8580 |
| Catalog Number | 70102.8580 |
| 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 | 2015-05-22 |