MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for ROTOPRONE THERAPY SYSTEM manufactured by Arjohuntleigh Ab.
[145780698]
High acuity/critically ill patient was supine in a rotoprone therapy system bed for an extended period of time (6 days) without ability to reposition due to pulmonary and hemodynamic instability. Inability to rotate the patient for approximately 16 hours due to decreasing oxygen saturation and potential respiratory arrest, along with the patient was too large for the rotoprone resulted in one unstageable pressure injury, five stage 2 pressure injuries, and three deep tissue pressure injuries. Nursing concern: the rotoprone bed can cause pressure injuries as a result of the outdated support surfaces (climate control and pressure redistribution). Also, the rotoprone needs a better fit for bariatric patients. This patient was in excess of 350 lbs which is contraindicative per rotoprone therapy, critical care order set. Nursing worked closely with the rotoprone representative prior to and during pronging. The rep. Recommended the rotoprone based on the patient's girth measurements versus her weight.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8631761 |
| MDR Report Key | 8631761 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-03-28 |
| Report Date | 2019-04-29 |
| Date Reported to FDA | 2019-04-29 |
| Date Reported to Mfgr | 2019-05-22 |
| Date Added to Maude | 2019-05-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | ROTOPRONE THERAPY SYSTEM |
| Generic Name | BED, PATIENT ROTATION, POWERED |
| Product Code | IKZ |
| Date Received | 2019-05-22 |
| Returned To Mfg | 2019-03-31 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH AB |
| Manufacturer Address | 12625 WETMORE ROAD SUITE 308 SAN ANTONIO TX 78247 US 78247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-22 |