MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; BED, PATIENT ROTATION, POWERED

Model Number 209800-R

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Bradycardia (1751); Death (1802); Low Oxygen Saturation (2477); Loss Of Pulse (2562)

Event Date 09/26/2016

Event Type  Death  

Event Description

Patient in a prone therapy bed, was in prone position at 15 degrees.With aide of 2 rn's placed patient to supine position with the goal to assess the skin/ett/cvp/arterial lines.Patient being monitoring closely for signs of decompensation.After 5 minutes noticed desaturations, so quickly with the aide of the 2 other rn's placed cushions back onto patient and attempted to place back into prone position.The bed kept alarming that the chest buckles/straps were loose and would not let us complete prone position.Attempted at least 3 times to fix the chest buckles/straps however the alarm kept ringing.At this time noticed that patient started to desaturate and hr dropped to 40's.A chemical code was called.Patient became asystole/pea.Medication resuscitation became futile and with family attempts were called off.Patient repositioning with prone therapy bed.Manufacturer response for prone therapy bed, rotoprone (per site reporter: manufacturer notified to receive bed for inspection.Biomedical requesting report and follow up.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 12625 wetmore rd ste 308; san antonio TX 78247
• MDR Report Key: 5996101
• MDR Text Key: 56362908
• Report Number: 5996101
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PATIENT IN A PRONE THERAPY BED, WAS IN PRONE POSIT
• Patient Outcome(s): Death
• Patient Age: 58 YR