MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE

Model Number 209500

Device Problems Sticking (1597); Device Displays Incorrect Message (2591)

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

Event Date 01/28/2014

Event Type  Death  

Event Description

The following was reported to arjohuntleigh by the nurse: on (b)(6) 2014, the bed was alarming hatch or buckle open.The nurse tightened all buckles and hatches then re-booted the bed.The bed would not mechanically prone after following instructions on the computerized screen.Arjohuntleigh customer technical services was called and per the arjohuntleigh technical service rep's instructions the pt was placed in the supine position, the bed was unplugged, the battery button was pushed, and then the bed was plugged back in.While waiting for the bed to re-boot, the pt's oxygen saturation decreased exponentially.Once the bed was re-booted the nurse attempted to rotate the pt to the prone position.The bed rotated up to 62 degrees on the left side, and stopped with error messages displaying again.At this time, the pt lost a pulse.The cpr button and emergency handle were released, the pt was rotated to the supine position and cpr started.Cpr was unsuccessful and subsequently the pt died.

Manufacturer Narrative

This report is being filed by the mfr arjohuntleigh inc.Please note that previous medwatch reports for this product may have been submitted from the mfg site (b)(4).As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.Add'l info will be provided upon conclusion of the mfr investigation.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd, ste 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore rd, ste 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 3667359
• MDR Text Key: 19022644
• Report Number: 3010048749-2014-00004
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death