MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for 9400 STROBE LIGHT UNIT manufactured by Pentax Of America, Inc..
[175669408]
The 9400 strobe light unit developed corrosion of the halogen light bulb, causing the halogen bulb to fail before its expected life span. This has occurred on 4 occasions and the halogen bulbs have all failed before 10 hrs of use. Unit sn (b)(4). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092317 |
| MDR Report Key | 9601345 |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-01-09 |
| 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 | 9400 STROBE LIGHT UNIT |
| Generic Name | LARYNGOSTROBOSCOPE |
| Product Code | EQL |
| 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 | 2020-01-16 |