MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-02 for WELCH ALLYN PROXENON LIGHT SOURCE N344 manufactured by Welchallyn.
[126092602]
A storz telescope was connected to a welch allyn light source - the metal end on the cable was so hot inside the laryngoscope that it caused burn to pt's lower lip. Possible design flaw that karl storz light cable for scope equipment can universally plus in to welch allyn light source that has an outlet labeled "storz" but is designed for head lamps only. When our team tested the karl storz cable with laryngoscope with the welch allyn light source the metal on the laryngoscope was too hot to touch around 30 mins (light cable inserted inside the laryngoscope). Therapy date: (b)(6) 2018. Diagnosis or reason for use: scope procedure - lysis of anterior laryngeal web.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8033723 |
| MDR Report Key | 8033723 |
| Date Received | 2018-11-02 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-09-20 |
| Date Facility Aware | 2018-09-20 |
| Report Date | 2018-10-26 |
| Date Added to Maude | 2018-11-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | WELCH ALLYN PROXENON LIGHT SOURCE |
| Generic Name | PROXENON LIGHT SOURCE |
| Product Code | FST |
| Date Received | 2018-11-02 |
| Model Number | N344 |
| Lot Number | UL / IEC 60601-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCHALLYN |
| Manufacturer Address | 4619 JORDAN ROAD SKANEATELES FALLS NY 13152 US 13152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-11-02 |