N
Patient 1
THERE IS NO REPORT OF A DEVICE MALFUNCTION OR FAILURE. THE ROOT CAUSE OF THE COMPLAINT EVENT IS NOT RELATED TO THE DESIGN OR FUNCTION OF THE DEVICE. IT IS NOT KNOWN WHY THE PATIENT STRUCK THE HFA3.
MAUDE MDR 7431331
- MDR report key
- 7431331
- Report number
- 2918630-2018-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-03-13
- Date received
- 2018-04-13
- 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. WILLIAM GUSTAFSON
- Address
- 5160 HACIENDA DRIVE DUBLIN CA 94568 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HUMPHREY FIELD ANALYZER 3 | PERIMETER, AUTOMATIC, AC-POWERED | CARL ZEISS MEDITEC, INC. | HPT | 840 | 266002-1145-774 | N/A | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-04-13 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT PRIOR TO AN EXAM, WHILE SITTING DOWN, AN ELDERLY HANDICAPPED PATIENT HIT THE HUMPHREY FIELD ANALYZER (AREA ABOVE THE HEADREST) AND SUFFERED A LACERATION. THE PATIENT WAS ON BLOOD THINNING MEDICATION AND AS A RESULT, THE WOUND BLED HEAVILY. MEDICAL INTERVENTION (OF AN UNKNOWN NATURE) WAS REPORTED TO BE REQUIRED.