MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-25 for MULTICARE 56011347B-02 manufactured by Linet Americas.
[58297362]
Patient Sequence No: 1, Text Type: N, H10
[58297363]
The patient's bed froze while the patient was in rotation mode at 15 degrees. The patient was a critically ill patient in ards that required rotation for her illness. We tried everything to fix the bed such as turning it off, unplugging it, pushing every button etc. Error code 4 and 13 appeared on the screen. We had to move the patient to a new bed with her at 15 degrees. This not only was potentially dangerous for the patient but it could have caused harm to our staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6054067 |
| MDR Report Key | 6054067 |
| Date Received | 2016-10-25 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-10-04 |
| Report Date | 2016-10-18 |
| Date Reported to FDA | 2016-10-18 |
| Date Reported to Mfgr | 2016-10-18 |
| Date Added to Maude | 2016-10-25 |
| 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 |
| 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 | MULTICARE |
| Generic Name | BED, PATIENT ROTATION, MANUAL |
| Product Code | INY |
| Date Received | 2016-10-25 |
| Model Number | 56011347B-02 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINET AMERICAS |
| Manufacturer Address | 10420 HARRIS OAKS BLVD. SUITE R CHARLOTTE NC 28269 US 28269 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-25 |