N
Patient 1
MAUDE MDR 7302142
- MDR report key
- 7302142
- Report number
- 7302142
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-02-23
- Date received
- 2018-02-28
- Adverse event
- 0
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ELI 380 | ELECTROCARDIOGRAPH | MORTARA INSTRUMENT, INC. | DPS | ELI380 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-02-28 | 0 |
Event Narratives#
D
Patient 1
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.