MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for HEATER-COOLER UNIT HCU 40 HIGH VOLTAGE 70104.4054 manufactured by Maquet Cardiopulmonary Ag.
[139062752]
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139062753]
It was stated that when startup of device the hcu40 unit, a vacuum valve was leaking, causing pop noise and burning smell before it triggered the mains supply. No patient was involved. Internal reference: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2019-00047 |
| MDR Report Key | 8370589 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-06-13 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-06-13 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2019-02-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | 76437 RASTATT |
| Manufacturer Country | GM |
| Manufacturer Phone | 4972229321 |
| Manufacturer G1 | BERND RAKOW |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | 76437 RASTATT |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HEATER-COOLER UNIT HCU 40 HIGH VOLTAGE |
| Generic Name | HEAT-EXCHANGER, CARDIOPULMONARY BYPASS |
| Product Code | DTR |
| Date Received | 2019-02-26 |
| Model Number | HCU 40 HIGH VOLTAGE |
| Catalog Number | 70104.4054 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-26 |