MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-29 for RITTER 355-028 manufactured by Midmark Corp..
[5890452]
Midmark was notified that a light fell from the ceiling mount while a patient was in the room. No injuries sustained.
Patient Sequence No: 1, Text Type: D, B5
[13432252]
The unit was returned and is currently being assessed. Additional relevant information will be shared when the investigation report becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1523530-2015-00003 |
| MDR Report Key | 4755259 |
| Report Source | 05 |
| Date Received | 2015-04-29 |
| Date of Report | 2015-04-29 |
| Date of Event | 2014-03-30 |
| Date Mfgr Received | 2015-03-30 |
| Device Manufacturer Date | 2015-01-20 |
| Date Added to Maude | 2015-06-12 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANE CARROLL |
| Manufacturer Street | 60 VISTA DR. P.O. BOX 286 |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375268604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RITTER |
| Generic Name | 355 LIGHT SYS |
| Product Code | EAZ |
| Date Received | 2015-04-29 |
| Returned To Mfg | 2015-04-10 |
| Model Number | 355-028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2015-04-29 |