MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. TRIADYNEPROVENTA

Device Problem Unintended System Motion (1430)

Patient Problems Hypoventilation (1916); No Information (3190)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

It has been claimed by the facility that the triadyne proventa bed was defective.It was switching into pulsation mode without anyone touching it.Nurse turns pulsation mode off; however, after a minute it switched back into this mode again.It has been alleged that this mode makes the air in the mattress' bladders and prone pillow of the chest and hips to be too soft/underinflated.This causes the pt's trunk of body to sink and not be ventilated properly.Also, the prone pillows under the upper chest and hips have been described by the facility as being too soft/underinflated which also results in insufficient lift/support of pt while in the prone/face down position.The facility states that this affects breathing and ventilation on a very sick pt with already poor lung function.Additionally, we have received the info that the bed is switching into "instaflate" mode without anyone touching it.No further info about the pt outcome has become available despite our best efforts.

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the mfg site kinetics concept inc (under registration number 1625774).From november 2012 to october 31 2014 medwatch reports related to complaints of this product were submitted under registration number 3010048749.Since this registration number is no longer valid, reports related to complaints of this product will be submitted under registration number 3009988881.When reviewing similar reportable events for triadyne range we have not been able to find any similar fault description compared to the situation investigated here (unintended/uncommanded activation of the mattress function).There is no trend observed for reportable complaints with this failure for triadyne proventa beds.Based on the info collected to date, provided problem description and inspection of the device, we have been unable to confirm or recreate the issues claimed by the customer.The device was inspected by an arjohuntleigh rep who established that the device was in full working condition.No issues have been found.As part of the inspection, the bed was run for 3 hours.During that test the failure did not occur again.As the recreation of the issue was not possible, we were not able to establish any possible further root cause.Despite our best efforts we were unable to clarify whether the facility staff adjusted the air pressure correctly when placing the pt or whether the mattress function had been locked out by the operator of the device in order to prevent unintentional system operation.Based on the collected info and the fact that the device was in full working condition it seems most likely that the issue was caused by an unintentional operation of the device function.In summary, the device was being used at the time of the event.It suffered a malfunction even though it met specifications.It stopped performing as intended, most likely due to a use error.There were no injuries reported.Given the circumstances and the fact that this incident appears to be an isolated one, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: TRIADYNEPROVENTA
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout dr; san antonio TX 78219 000
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout dr; san antonio TX 78219 000
• Manufacturer Contact: pamela wright ; 12625 wetmore rd ste 308; san antonio, TX 78247-0000 ; 2102787040
• MDR Report Key: 4611589
• MDR Text Key: 5656773
• Report Number: 3009988881-2015-00013
• 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: Inspection
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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