MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-18 for MAQUET CARDIOPULMONARY AG NI 70102.7652 manufactured by Maquet Cardiopulmonary Ag.
[18067700]
It was reported, while performing a function check a clicking sound occured that was not present initially. After operating unit overnight at full 250 rpm's clicking ceased. Upon disassembly i noticed that (upper) belt was twisted and the (lower) belt was broken. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18431430]
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device, maquet cardiopulmonary (b)(4). Pump product number: mcp00703309. Pump serial number: (b)(4). The actual device has not been evaluated yet. A supplemental medwatch will be submitted upon receipt of additional info. Items marked ni are unknown to us at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00255 |
| MDR Report Key | 4620299 |
| Report Source | 05,06 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-03-04 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2015-05-04 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| 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 | MAQUET CARDIOPULMONARY AG |
| Generic Name | HL 20 CONSOLE BASE |
| Product Code | DPW |
| Date Received | 2015-03-18 |
| Model Number | NI |
| Catalog Number | 70102.7652 |
| Lot Number | NA |
| 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 | 1. Required No Informationntervention | 2015-03-18 |