MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-10-08 for MAQUET CARDIOPULMONARY AG 70102.8580 manufactured by Maquet Cardiopulmonary Ag.
[3853312]
It was reported that during preventative maintenance service an electrical short developed. The cable and insulation became crushed between the case and base of the machine during the repair work. Initial electrical testing did not indicate an electrical short. Over a period of ten days, the insulation broke down and caused the residual current device (rcd) to trip during movement of the machine. The equipment could be run on a battery but could not be connected to the main due to the short. The perfusionist indicated the malfunction did not occur during a procedure. Reference: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11241133]
(b)(4). Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report. Maquet (b)(4) has performed an investigation by remote diagnosis. The device is not being returned for evaluation. The device will be repaired on site by a service technician. A supplemental medwatch will be submitted if additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2013-00050 |
| MDR Report Key | 3459118 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-10-08 |
| Date of Report | 2013-09-09 |
| Date of Event | 2013-09-09 |
| Date Facility Aware | 2013-09-09 |
| Report Date | 2013-10-08 |
| Date Mfgr Received | 2013-09-11 |
| Date Added to Maude | 2014-01-09 |
| 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 DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097284 |
| 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 |
| 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 | 2013-10-08 |
| Model Number | 70102.8580 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-10-08 |