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

Model Number 209800

Device Problems Difficult or Delayed Positioning (1157); No Display/Image (1183); Device Difficult to Program or Calibrate (1496)

Patient Problem No Code Available (3191)

Event Date 11/17/2019

Event Type  malfunction  

Event Description

Rotoprone bed malfunctioning during day shift on [date redacted].Touch screen not responding despite multiple attempts.Staff was able to prone pt despite malfunctioning touch screen.Rotoprone bed supported notified approx at 19:00 on [date redacted].Instructed by rotoprone rep to call back when ready to supine in order to trouble shoot via phone.Nursing staff asked for new bed secondary to worsening glitches with bed.Second call to rotoprone support on [date redacted] at approx 8:45.Charge nurse was on the phone for approx 40 minutes to open a service ticket.Return phone call by rotoprone rep approx 11 am.At this time patient was due for supine position.Charge nurse strongly encouraged/recommended new bed, but was met with some resistance to provide new bed.At approx 13:00 new bed arrived but tech had increased difficulty with calibrating new bed.At this point pt.Decompensated and staff was unable to transfer pt to new bed.The touch screen continue to malfunction and was not allowing us to prone pt.Screen would default to supine therapy rather than prone option.Finally we were able to prone pt but at approx 18:00 bed error message and thus called rotoprone support and faced time to troubleshoot.Pt continues on old bed and waiting to be transferred to new appropriate bed.

• Brand Name: ROTOPRONE THERAPY SYSTEM
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG; 2349 w lake st # 250; addison IL 60101
• MDR Report Key: 10740357
• MDR Text Key: 213225378
• Report Number: 10740357
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209800
• Device Catalogue Number: 209800
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10950 DA
• Patient Weight: 86