MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-01-09 for SLEEPSAFE SLEEPSAFER SR-MP-MG-T manufactured by Sleepsafe Beds.
[132565608]
Dme technician calls and alleges the user sustained a finger injury. The user caught their finger(s) between the back panel gap. Dme technician advised that the pins that secure panel-to-panel were not installed. Without the dowel pins, the panels can be flexed apart opening a pinch point. The bed was assembled in the home (b)(6) 2017. Technician advised there are no work order notes or other documentation that explain why the pins were not installed. Presumably they were omitted on initial install or possible subsequent move. We are overnighting pins for the technician to install. For preventive action, we will pre-install the pins before we ship.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008061384-2018-00001 |
| MDR Report Key | 8232172 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-01-09 |
| Date of Report | 2019-01-08 |
| Date Mfgr Received | 2018-12-10 |
| Device Manufacturer Date | 2017-12-01 |
| Date Added to Maude | 2019-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. ROBERT BALDACCI |
| Manufacturer Street | 3629 REED CREEK DRIVE |
| Manufacturer City | BASSETT VA 24055 |
| Manufacturer Country | US |
| Manufacturer Postal | 24055 |
| Manufacturer Phone | 8668522337 |
| Manufacturer G1 | SAME |
| Manufacturer Street | SAME |
| Manufacturer City | SAME VA 24055 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 24055 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLEEPSAFE |
| Generic Name | SAFETY BED |
| Product Code | FNJ |
| Date Received | 2019-01-09 |
| Model Number | SLEEPSAFER |
| Catalog Number | SR-MP-MG-T |
| Lot Number | 26068 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SLEEPSAFE BEDS |
| Manufacturer Address | 3629 REED CREEK DRIVE BASSETT VA 24055 US 24055 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-09 |