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 2015-07-28 for HL-20 TWIN PUMP 70102.8692 MCP00703277 manufactured by Maquet Cardiopulmonary Ag.
[6037217]
On (b)(6) 2013 at the (b)(6), it was reported through the msupport system complaint number (b)(4) that the motor control board and control board on the tpm 20-330 twin roller pump module serial number (b)(4) were defective after the unit was upgraded to software version 2. 5. The ssu reported that the unit displayed an a/d converter (+5v error). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[14307835]
Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). The device was evaluated by a ssu technician and the motor control board and control board were found to be defective and were replaced (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-00921 |
| MDR Report Key | 4944785 |
| Report Source | 01,05,06 |
| Date Received | 2015-07-28 |
| Date of Report | 2013-10-11 |
| Date of Event | 2013-10-11 |
| Date Facility Aware | 2013-10-11 |
| Report Date | 2013-10-11 |
| Date Reported to Mfgr | 2013-10-11 |
| Date Mfgr Received | 2013-10-11 |
| Date Added to Maude | 2015-07-28 |
| 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 Contact | TINA EVANCHO |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097265 |
| Manufacturer G1 | MAQUET CARDIOPULMONARY AG |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT, 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HL-20 TWIN PUMP |
| Generic Name | FLOWMETER, BLOOD, CARDIOVASCULAR |
| Product Code | DPW |
| Date Received | 2015-07-28 |
| Model Number | 70102.8692 |
| Catalog Number | MCP00703277 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT, 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-28 |