MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-11-21 for RITTER 355-028 manufactured by Midmark Corp..
[21719572]
Customer stated that midmark 355 light had (4) mounting screws shear and the light fell from its ceiling mounting. No injuries occurred.
Patient Sequence No: 1, Text Type: D, B5
[22148166]
Photographic evidence was evaluated and showed that components of the midmark 355 light were modified by someone other than midmark. It is unk if this adulteration contributed to the failure. Additional testing was performed on a similar midmark 355 light and found no failure would occur with normal use and preventative maintenance. Notification was given to the customer on what normal use and preventative maintenance is required for this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2014-00016 |
| MDR Report Key | 4281453 |
| Report Source | 06 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-10-21 |
| Date Mfgr Received | 2014-10-21 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2014-12-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG RAMMEL |
| Manufacturer Street | 60 VISTA DR. |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375263662 |
| Single Use | 0 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RITTER |
| Generic Name | PROCEDURE LIGHT |
| Product Code | EAZ |
| Date Received | 2014-11-21 |
| Returned To Mfg | 2014-11-19 |
| Model Number | 355-028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | VERSAILLES OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-21 |