MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for HUMPHREY FIELD ANALYZER 3 840 266002-1145-774 manufactured by Carl Zeiss Meditec, Inc..
[105511643]
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.
Patient Sequence No: 1, Text Type: N, H10
[105511644]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918630-2018-00001 |
| MDR Report Key | 7431331 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-03-14 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-14 |
| Device Manufacturer Date | 2016-12-12 |
| Date Added to Maude | 2018-04-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC, INC. |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94568 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUMPHREY FIELD ANALYZER 3 |
| Generic Name | PERIMETER, AUTOMATIC, AC-POWERED |
| Product Code | HPT |
| Date Received | 2018-04-13 |
| Model Number | 840 |
| Catalog Number | 266002-1145-774 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC, INC. |
| Manufacturer Address | 5160 HACIENDA DRIVE DUBLIN CA 94568 US 94568 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-13 |