MAUDE Adverse Event Report: ARJOHUNTLEIGH AB ROTOPRONE THERAPY SYSTEM; BED, PATIENT ROTATION, POWERED

Device Problems Product Quality Problem (1506); Patient-Device Incompatibility (2682)

Patient Problem Pressure Sores (2326)

Event Date 03/28/2019

Event Type  malfunction  

Event Description

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three deep tissue pressure injuries.Nursing concern: the rotoprone bed can cause pressure injuries as a result of the outdated support surfaces (climate control and pressure redistribution).Also, the rotoprone needs a better fit for bariatric patients.This patient was in excess of 350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.

• Brand Name: ROTOPRONE THERAPY SYSTEM
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH AB; 12625 wetmore road suite 308; san antonio TX 78247
• MDR Report Key: 8631761
• MDR Text Key: 145780698
• Report Number: 8631761
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/29/2019,04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Weight: 165