N
Patient 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
MAUDE MDR 8070035
- MDR report key
- 8070035
- Report number
- 9610816-2018-00314
- Event key
- 0
- Event type
- 3
- Date received
- 2018-11-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. BETTY HARRIS
- Address
- HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MP5 | PATIENT MONITOR | PHILIPS MEDICAL SYSTEMS | BZQ | M8105A (865024) | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-11-14 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTED THAT THE SCREEN IS LOCKED, NO MORE ACCESS TO ANY MENU. NO DEATH OR PATIENT /USER INJURY OR HARM WAS REPORTED.