MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-29 for PREVALON AIRTAP 7450 manufactured by Sage Products Llc.
[118554869]
Staff went to use this device and they turned it on and as they moved it they noticed a spark/arc where the power cord meets the device. The arc occurred because the power cord has made it way far enough out of the power receptacle even though the power cord bracket was in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7826009 |
| MDR Report Key | 7826009 |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-22 |
| Report Date | 2018-08-27 |
| Date Reported to FDA | 2018-08-27 |
| Date Reported to Mfgr | 2018-08-29 |
| Date Added to Maude | 2018-08-29 |
| 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 | PREVALON AIRTAP |
| Generic Name | MOBILE PATIENT TRANSFER/REPOSITIONING DEVICE |
| Product Code | FMR |
| Date Received | 2018-08-29 |
| Model Number | 7450 |
| Catalog Number | 7450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS LLC |
| Manufacturer Address | 3909 THREE OAKS ROAD CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |