MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-02-06 for 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP 190395 manufactured by Concord Manufacturing.
[99217369]
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[99217370]
A biomedical technician (biomed) at a user facility reported that a fresenius 2008k@home hemodialysis (hd) machine had a burned power plug. The burned power plug was noticed during regular inspection. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. The plug was the original fresenius part on the machine. The biomed reported that there was no melting, burning smell, smoke, spark, or flame observed. The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components. The machine has approximately 4,500 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet. The biomed replaced the plug, which resolved the issue. The biomed reported that the machine is ready for service. The power plug was stated to be available to be returned to the manufacturer for physical evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2018-00383 |
| MDR Report Key | 7246271 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-02-06 |
| Date of Report | 2018-02-13 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2018-02-12 |
| Device Manufacturer Date | 2007-11-22 |
| Date Added to Maude | 2018-02-06 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | CONCORD MANUFACTURING |
| Manufacturer Street | 4040 NELSON AVENUE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2018-02-06 |
| Catalog Number | 190395 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONCORD MANUFACTURING |
| Manufacturer Address | 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-06 |