MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for ELI 380 ELI380 manufactured by Mortara Instrument, Inc..
[101175976]
Patient Sequence No: 1, Text Type: N, H10
[101175977]
While attempting to perform an ecg the nurse activated the wireless access module (wam), the device would not connect with the mortara eli380 ecg machine. Another machine was used with the same result (different wam module also. Staff changed batteries, attempted to use the other wam modules to see if they had gotten mixed up - it did not work. Staff called for another machine and the ecg was performed after a short delay, no patient harm. Manufacturer response for ecg machine, mortara (per site reporter) discussed with service technician issue was likely related to electrical interference of some type, which probably resolved by the time the other machine, arrived. Could not duplicate the issue. We have ordered a back-up hard wired trunk cable to use in case of future issues with the wireless module to minimize delay time to diagnostic ecg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7302142 |
| MDR Report Key | 7302142 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-02-23 |
| Report Date | 2018-02-23 |
| Date Reported to FDA | 2018-02-23 |
| Date Reported to Mfgr | 2018-02-23 |
| Date Added to Maude | 2018-02-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 380 |
| Generic Name | ELECTROCARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2018-02-28 |
| Model Number | ELI380 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORTARA INSTRUMENT, INC. |
| Manufacturer Address | 7865 N 86TH. ST MILWAUKEE WI 53224 US 53224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-28 |