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 2013-08-26 for MAQUET CARDIOPULMONARY AG 70102.8580 manufactured by Maquet Cardiopulmonary Ag.
[17446914]
It was reported that while the heart-lung-machine hl 20 was in standby for battery charging, the power supply board inside the hl 20 burned. This occurred prior to clinical use and not in the operation room. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17672675]
Maquet medical systems, usa submits this report on behalf of the legal mfr of the device, maquet cardiopulmonary (b)(4). Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report. Maquet cardiopulmonary (b)(4) requested the return of the defective heart-lung-machine. Pictures of the unit have been received and reviewed. At this time, the heart-lung-machine is still located in (b)(6). Upon receipt of the unit, the (b)(4) facility will conduct an investigation. A supplemental medwatch will be submitted when the eval is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2013-00043 |
| MDR Report Key | 3349605 |
| Report Source | 01,05,06 |
| Date Received | 2013-08-26 |
| Date of Report | 2013-07-31 |
| Date of Event | 2013-07-27 |
| Date Facility Aware | 2013-07-31 |
| Report Date | 2013-08-26 |
| Date Mfgr Received | 2013-07-31 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2013-11-21 |
| 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 | JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DR |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097753 |
| Manufacturer G1 | MAQUET CARDIOPULMONARY AG |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAQUET CARDIOPULMONARY AG |
| Generic Name | HL 20 4-PUMPS CONSOLE BASE |
| Product Code | DPW |
| Date Received | 2013-08-26 |
| Model Number | 70102.8580 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 44 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-26 |