MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-10-16 for PLEX ELITE 9000 SS-OCT 266002-1163-096 manufactured by Carl Zeiss Meditec, Inc..
[123846160]
A health care professional (hcp) reported that a user had received an electric shock while operating the plex elite 9000 power table. The user was examined by local medical professionals and it was reported that the user had not been injured. A photo has been provided to the manufacturer showing damaged insulation on a wire in the enclosure of the power table's up/down switch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918630-2018-00002 |
| MDR Report Key | 7969536 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-16 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2017-01-09 |
| Date Added to Maude | 2018-10-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEX ELITE 9000 SS-OCT |
| Generic Name | TOMOGRAPHY, OPTICAL COHERENCE |
| Product Code | OBO |
| Date Received | 2018-10-16 |
| Model Number | 9000 |
| Catalog Number | 266002-1163-096 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-10-16 |