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..
[175669241]
The 9400 strobe light unit developed corrosion of the wire supplying electricity to the xenon light bulb causing the wire to let out electrical sparks when the xenon light bulb was in use. Unit sn (b)(4). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092318 |
| MDR Report Key | 9601350 |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-09-04 |
| 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 | 0 |
| 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 |