MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-11 for ELI 280 ELI280 manufactured by Mortara Instrument, Inc..
[88972143]
Patient Sequence No: 1, Text Type: N, H10
[88972144]
Ekg gives error message that leads are not connected when they are. Evaluated by bio met, unable to identify cause, believes leads either need to be cleaned or replaced. Bio med does not stock or order replacement leads, the department will have to order.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6940129 |
| MDR Report Key | 6940129 |
| Date Received | 2017-10-11 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-08-28 |
| Report Date | 2017-09-29 |
| Date Reported to FDA | 2017-09-29 |
| Date Reported to Mfgr | 2017-09-29 |
| Date Added to Maude | 2017-10-11 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELI 280 |
| Generic Name | ELECTROCARDIOGRAPH |
| Product Code | LOS |
| Date Received | 2017-10-11 |
| Model Number | ELI280 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORTARA INSTRUMENT, INC. |
| Manufacturer Address | 7865 NORTH 86TH STREET MILWAUKEE WI 53224 US 53224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-11 |