D
Patient 1
THE USER FACILITY REPORTED THAT THEIR MONITOR BLANKED OUT TWICE DURING A PATIENT PROCEDURE. THE MONITOR BLANKED OUT AGAIN DURING THE BEGINNING OF ANOTHER PATIENT PROCEDURE.
MAUDE MDR 4170769
- MDR report key
- 4170769
- Report number
- 1000404456-2014-00009
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-09-15
- Date received
- 2014-10-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MS. KATHRYN CADORETTE
- Address
- 5960 HEISLEY ROAD MENTOR OH 44060 US
- Phone
- 440-440-4403
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HARMONY IQ 3600 INTEGRATION SYSTEM | INTEGRATION SYSTEM | VTS MEDICAL SYSTEMS | LMD | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-10-14 | 0 |
Event Narratives#
N
Patient 1
INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
N
Patient 1
A STERIS SERVICE SPECIALIST ARRIVED AT THE FACILITY, INSPECTED THE INTEGRATION SYSTEM AND DETERMINED THE ISSUE WAS CAUSED BY AN INTERMITTENT CAMERA ISSUE. WHILE ONSITE, THE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE TECHNICIAN MADE ADJUSTMENTS TO THE INTEGRATION SYSTEM, TESTED THE UNIT AND RETURNED IT TO SERVICE.