MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06,07,08 report with the FDA on 2014-11-26 for MAQUET HL-20 TWIN PUMP MCP00703323 70103.5075 manufactured by Maquet Cardiopulmoary Ag.
[18634791]
On (b)(4) 2011, the equipment distributor, medtronix medical supplies, (b)(4), was installing a new hl20 at (b)(6). The distributor reported that during the installation of the twin pump module tpm 20-330 twin roller pump (article number: (b)(4)) that the led switch on the right side of the tpm was defective. The distributor reported the event to the maquet service technician on (b)(4) 2011. Reference: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19009408]
(b)(4). Maquet cardiopulmonary ag provides product failure investigation, analysis, and resolution for the device described in this report. The defective led was replaced. Reference: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2014-00539 |
| MDR Report Key | 4280436 |
| Report Source | 00,01,06,07,08 |
| Date Received | 2014-11-26 |
| Date of Report | 2011-11-09 |
| Date of Event | 2011-11-04 |
| Date Facility Aware | 2011-11-09 |
| Report Date | 2011-11-09 |
| Date Reported to Mfgr | 2011-11-09 |
| Date Mfgr Received | 2011-11-09 |
| Device Manufacturer Date | 2010-05-31 |
| Date Added to Maude | 2014-11-26 |
| 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 |
| Health Professional | 0 |
| 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 CARDIOPULMOARY 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 | MAQUET HL-20 TWIN PUMP |
| Generic Name | FLOWMETER, BLOOD, CARDIOVASCULAR |
| Product Code | DPW |
| Date Received | 2014-11-26 |
| Model Number | MCP00703323 |
| Catalog Number | 70103.5075 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMOARY AG |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT, 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-26 |