MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE

Device Problems False Alarm (1013); Sticking (1597)

Patient Problem Death (1802)

Event Date 01/23/2014

Event Type  Death  

Event Description

The following was reported to arjohuntleigh by the nurse: on (b)(6) 2014, the bed had an error message that stated the chest buckle was not secure.All of the buckles were checked and appeared secure.The bed was unable to mechanically rotate to the prone position.Subsequently at an unknown time the patient died.The nurse reported that the patient's death was unrelated to the incident.Arjohuntleigh is submitting this report before the complete investigation due to an abundance of caution because of the patient's death.All additional information will be provided in a supplemental report.

Manufacturer Narrative

This report is being filed by the manufacturer arjohuntleigh, inc.Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.Additional information will be provided upon conclusion of the manufacturer 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: 3624446
• MDR Text Key: 4131749
• Report Number: 3010048749-2014-00003
• 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: 01/24/2014

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: 01/24/2014
• Initial Date FDA Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death