MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-09 for RC ULTRA HI-LO 850 BED RCUHLB850BED manufactured by Joerns Healthcare.
[104684427]
Patient Sequence No: 1, Text Type: N, H10
[104684428]
It was reported to the manufacturer by the end user, per the end user, patient was trying to get out of bed and slid off the mattress between the rails, falling to the floor. The trachea tube got caught on the side rail as the fall occurred. The trachea did bleed but was able to be controlled and assessed by the facility. Complaint# (b)(4) was entered into our system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2018-00015 |
| MDR Report Key | 7406827 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-03-15 |
| Date Added to Maude | 2018-04-09 |
| 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 | 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 | RC ULTRA HI-LO 850 BED |
| Generic Name | ELECTRIC PATIENT BED |
| Product Code | OSI |
| Date Received | 2018-04-09 |
| Model Number | RCUHLB850BED |
| Catalog Number | RCUHLB850BED |
| 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 | 1. Other | 2018-04-09 |