MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-21 for AC POWERED INSTRUMENT STAND - 777 WALL TRANSFORMER SET(INCLUDING OTOSCOPES, OPH 408282 manufactured by Welch Allyn, Inc..
[67820002]
Patient Sequence No: 1, Text Type: N, H10
[67820003]
While patient was receiving o2 flow therapy in the picu, the oto-ophthalmoscope diagnostic set's plug in ac power connector shorted and caused an electrical flash and sparks resulting in damage to the connector and surrounding ac outlet. The patient was disconnected from monitoring and o2 therapy and evacuated from the room. The clinician removed the power connector from the ac outlet and notified management and engineering. Investigation determined that fluid from the disposable nebulizer had leaked onto the ac power connector and caused the short. Biomedical noted a possible design flaw in the connector that would allow fluid intrusion. Biomedical removed the device from picu for reporting to fda medwatch maude database and notification of the device manufacturer. No patient harm resulted from this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6345025 |
| MDR Report Key | 6345025 |
| Date Received | 2017-02-21 |
| Date of Report | 2017-02-16 |
| Date of Event | 2017-02-16 |
| Report Date | 2017-02-16 |
| Date Reported to FDA | 2017-02-16 |
| Date Reported to Mfgr | 2017-02-16 |
| Date Added to Maude | 2017-02-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | BIOMEDICAL ENGINEER |
| 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 | AC POWERED INSTRUMENT STAND - 777 WALL TRANSFORMER SET(INCLUDING OTOSCOPES, OPH |
| Generic Name | STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC |
| Product Code | HMF |
| Date Received | 2017-02-21 |
| Model Number | 777 |
| Catalog Number | 408282 |
| Lot Number | 15231 |
| Device Availability | Y |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | 4341 STATE STREET RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-21 |