N
Patient 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE, IT WILL BE PROVIDED IN FUTURE REPORTS. (B)(4).
MAUDE MDR 6329566
- MDR report key
- 6329566
- Report number
- 0002936485-2017-00190
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-01-23
- Date received
- 2017-02-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. VICTORIA MILICH
- Address
- 5900 OPTICAL COURT SAN JOSE CA 95138 US
- Phone
- 408-408-4087
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STRYKERVISION FLAT-PANEL MOUNTING ARM | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) | STRYKER ENDOSCOPY-SAN JOSE | BZN | 0240095200 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-14 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE ARM WAS NOT ABLE TO HOLD THE MONITOR AND THE MONITOR ALMOST FELL ON THE PATIENT. THERE WAS NO USER OR PATIENT HARM.