MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTORESTDELTA

Device Problems Misconnection (1399); Device Operational Issue (2914)

Patient Problem Death (1802)

Event Date 09/05/2014

Event Type  Death  

Event Description

It has been reported to arjohuntleigh, that a resident nurse discovered an exposed bracket under the patient's sacrum area, when she went to chang and clean under the patient.A service order was issued to collect asset serial number (b)(4), and deliver a replacement bed.However, the patient died of apparently unrelated causes while the replacement bed was in route.

Manufacturer Narrative

This report is being filed by the manufacturer arjohuntleigh, inc.Please not 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.When reviewing similar reportable events for rotoprone rotorestmi and reotorest delta therapy system, we have not been able to found any similar fault description compared to the situation investigated here: patient lying on the device with reversely assembled hatches.There is no trend observed for reportable complaints with this failure for rotorest delta therapy system.Based on the collected information, it has been determined that the contributory factor in the patient's death was advanced patient medical condition not a device condition.Please note that the patient's comorbidities included the following: acute respiratory distress syndrome (ards), septic shock and multiple organ dysfunction syndrome.The patient had some minor indentation on the skin across the buttocks area that did not require any medical intervention.The patient did not sustain any serious injuries from the hatches being misplaced.The patient's death was unrelated to the bed or to the misplaced hatches.Unfortunately, we have been unable to clarify where or when the hatch assembly was reversed.Up to this point ther is no indication that the device caused or contributed to the patient death.In summary, the device was being used, when the event occurred, for the patient treatment, the device contributed to the event since the patient was lying on the device, however, we could not foind any indication that the device actively caused or contributed to the event, it was merely present.Nevertheless as the hatches were reversed on the bed, it failed to meet its specification.Unfortunately, the patient who was lying on the bed, died while the replacement bed was in route.Given the circumstances and no number of similar events, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: ROTORESTDELTA
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 12625 wetmore road; suite 308; san antonio TX 78747
• Manufacturer (Section G): ARJOHUNTLEIGH, INC; 12625 wetmore road; ste 308; san antonio TX 78747
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78747 ; 2102787040
• MDR Report Key: 4151459
• MDR Text Key: 4914074
• Report Number: 3010048749-2014-00081
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/05/2014
• 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): Death
• Patient Age: 78 YR
• Patient Weight: 102