MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-23 for CHAMPION 54P UNKNOWN manufactured by Champion Mfg Inc..
[2488828]
A brand new electric cardiac chair was just introduced into the hospital for our post-surgical cardiac patients. The patient was placed from the bed to the new chair. The cardiac monitor displayed severe 60 cycle interference, thus making it impossible to properly display the ekg tracing on the physiological monitor. The patient was removed from the chair and the 60 cycle ac (alternate current) interference disappeared. ======================manufacturer response for 54p electric cardiac chair, champion (per site reporter)======================we spoke with an engineer at champion mfg, inc. And he said that this device didn't have an emi (electromagnetic interference) certificate. They are aware of the problem of the monitor interference. He responded to us they have no intention of attempting to correct this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2473541 |
| MDR Report Key | 2473541 |
| Date Received | 2012-02-23 |
| Date of Report | 2012-02-22 |
| Date of Event | 2012-02-19 |
| Report Date | 2012-02-22 |
| Date Reported to FDA | 2012-02-23 |
| Date Added to Maude | 2012-03-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAMPION |
| Generic Name | 54P ELECTRIC CARDIAC CHAIR |
| Product Code | GBB |
| Date Received | 2012-02-23 |
| Model Number | 54P |
| Catalog Number | UNKNOWN |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHAMPION MFG INC. |
| Manufacturer Address | ONE INVACARE WAY ELYRIA OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-23 |