MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2014-11-19 for POWER TABLE HFA 120 2660021124421 manufactured by Carl Zeiss Meditec Inc.
[16453432]
A perimeter and power table hfa 120 were set up at a customer site by a contractor in preparation for on-site staff training by the manufacturer's clinical applications specialist. A field service engineer, on-site for a different reason, noticed that the power table was wobbly. He inspected the table and determined that there was a problem with the weld joining the column to the base.
Patient Sequence No: 1, Text Type: D, B5
[16808457]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[40978145]
Added manufacturer narrative: a quality engineer (qe) performed an in-house inspection of the power table. The qe found that the table was missing a soldering weld specified by the design. The manufacturer replaced the table at the customer site. Correction: on initial report should have been "11/19/2014" instead of "10/19/2014". Update: method and conclusions.
Patient Sequence No: 1, Text Type: N, H10
[40978146]
Na
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918630-2014-00001 |
| MDR Report Key | 4329071 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2014-11-19 |
| Date of Report | 2016-03-21 |
| Date of Event | 2014-10-13 |
| Date Mfgr Received | 2014-10-21 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2014-12-22 |
| 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 | JUDY BRIMACOMBE |
| Manufacturer Street | 5160 HACIENDA DR. |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC INC |
| Manufacturer Street | 5160 HACIENDA DR. |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94568 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER TABLE |
| Generic Name | TABLE INSTRUMENT POWERED OPHTHALMIC |
| Product Code | HRJ |
| Date Received | 2014-11-19 |
| Model Number | HFA 120 |
| Catalog Number | 2660021124421 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC INC |
| Manufacturer Address | DUBLIN CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-19 |