N
Patient 1
MAUDE MDR 6940129
- MDR report key
- 6940129
- Report number
- 6940129
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-08-28
- Date received
- 2017-10-11
- Adverse event
- 3
- 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 280 | ELECTROCARDIOGRAPH | MORTARA INSTRUMENT, INC. | LOS | ELI280 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-11 | 0 |
Event Narratives#
D
Patient 1
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.