MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-14 for BARI10A BED BARI10ABED manufactured by Joerns Healthcare.
[111162504]
Patient Sequence No: 1, Text Type: N, H10
[111162505]
It was reported to the manufacturer by the end user, per the end user, "cna found pt, on ground, pt reported they were attempting to transfer from wheelchair to bed. Pt reports bed slipped out from under him and he landed on his knees. " the facility performed an x-ray on the left knee due to pain and it was negative for injury. (b)(4) were entered into our system to have the bed returned to joerns for investigation. As of this writing, the bed has not been returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2018-00031 |
| MDR Report Key | 7602277 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-14 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-05-16 |
| Date Mfgr Received | 2018-05-18 |
| Date Added to Maude | 2018-06-14 |
| 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 | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN ROAD |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Manufacturer G1 | JOERNS HEALTHCARE |
| Manufacturer Street | AVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL |
| Manufacturer City | MATAMOROS, TAMAULIPAS 87499 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 87499 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARI10A BED |
| Generic Name | ELECTRIC PATIENT BED |
| Product Code | OSI |
| Date Received | 2018-06-14 |
| Model Number | BARI10ABED |
| Catalog Number | BARI10ABED |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOERNS HEALTHCARE |
| Manufacturer Address | AVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL MATAMOROS, TAMAULIPAS 87499 MX 87499 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-14 |