MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. POTOPRONE

Device Problem Mechanical Problem (1384)

Patient Problems Death (1802); Low Oxygen Saturation (2477)

Event Date 01/26/2014

Event Type  malfunction  

Event Description

The following was reported to arjohuntleigh by the nurse: on (b)(6) 2014, the rotoprone bed was alarming and would not mechanically rotate.The nurses were able to manually rotate the bed to any position however while the bed was being prepared to manually rotate, the pt's oxygen saturation decreased to approx 25%.After the pt was placed in the prone position the oxygen saturation would stabilize.On (b)(6) 2014, the pt ultimately died due to the disease process.The pt's death was unrelated to the alarm situation or being manually proned.Arjohuntleigh is reporting this incident with an abundance of caution as a significant decrease in the pt's oxygen saturation occurred while the bed was being prepared to be manually proned.

Manufacturer Narrative

This report is being filed by the mfr arjohuntleigh, inc (registration #(b)(4)).Please note that previous medwatch reports for this product may have been submitted from the mfg site kinetic concepts, inc (under registration #(b)(6)).As on (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc and registration #(b)(4).Add'l info will be provided upon conclusion of the mfr investigation.

• Brand Name: POTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd; ste 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore; ste 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 3865308
• MDR Text Key: 4569089
• Report Number: 3010048749-2014-00005
• 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: 01/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other