MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for KDS SOFTWARE ON 9310HD COMPUTER manufactured by Pentax Of America, Inc..
[175851277]
The kds recording software that is provided on the 9310hd computer for recording laryngeal procedures, laryngeal videostroboscopy, and fiberoptic endoscopic evaluation of swallowing will intermittently freeze during the before named procedures with no system warning. This software / system issue has been reported to pentax medical on multiple occasions since july of 2017. The computers and software have been evaluated by pentax medical techs with no resolution of the problem. This is a serous issue during laryngeal procedure and swallowing evaluations as it can put the pt's health at risk. When the software freezes during an in office true vocal fold injection and medialization the physician is unable to view the larynx and where the needle is injecting the vocal fold. When the software freezes during a swallowing examination the clinician is unable to view the pharynx, larynx and upper airway, and may miss an aspiration event. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092319 |
| MDR Report Key | 9601362 |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-15 |
| Date of Event | 2017-07-07 |
| Date Added to Maude | 2020-01-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KDS SOFTWARE ON 9310HD COMPUTER |
| Generic Name | MEDICAL DEVICE DATA SYSTEM |
| Product Code | OUG |
| Date Received | 2020-01-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENTAX OF AMERICA, INC. |
| Manufacturer Address | MONTVALE NJ 07645 US 07645 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-16 |