N
Patient 1
THIS DEVICE IN THIS REPORT IS PRODUCT CODE: CCW, DEVICE CLASS: 1 REGULATION NUMBER: (B)(4) (510K EXEMPT).
MAUDE MDR 6754999
- MDR report key
- 6754999
- Report number
- 3010244187-2017-05000
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-06-13
- Date received
- 2017-07-31
- 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#
- Contact
- SHARON MURPHY
- Address
- 15 HAMPSHIRE STREET MANSFIELD MA 02048 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MCGRATH? MAC ENHANCED DIRECT LARYNGOSCOPE | LARYNGOSCOPE, NON-RIGID | AIRCRAFT MEDICAL LIMITED | CAL | 340-200-000 | 340-200-000 | UNKNOWN | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-07-31 | 0 | 1. O |
Event Narratives#
D
Patient 1
MEDTRONIC RECEIVED A REPORT THAT DURING PATIENT USE, THE DEVICE POWERED ON, THE LED ON THE TIP ILLUMINATED AND THE DISPLAY THEN WENT BLANK A FEW SECONDS AFTER POWERING ON. IT WAS STATED THAT THE SCREEN SHOWED 111MINS WHILE REMAINING BLANK. THE STAFF WAS ABLE TO SWITCH THE BATTERY ON SITE AND THE DEVICE WORKED PROPERLY AFTER THE REPLACEMENT OF THE BATTERY. THE CUSTOMER INDICATED THAT THE BATTERY CHANGE CAUSED A DELAY IN THE PROCEDURE/INTUBATION. IT WAS NOT SPECIFIED THE AMOUNT OF TIME OF THE DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT.