MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. TRIADYNEPROVENTA

Model Number 308900

Device Problem Unintended System Motion (1430)

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

Event Date 11/09/2014

Event Type  malfunction  

Event Description

It has been claimed by the facility that the triadyne proventa bed deflated while the patient was in supine position for 4 hours goal after being prone for 16 hours.It has been alleged that the deflated bed caused the patient's saturation to decrease to 79% and blood pressure to 79, which was related to poor breathing mechanics in that crunched/slumped position.Person 1 instaflated bed and notified person 2.Patient saturation did not improve, therefore the patient was returned to the prone position - saturation increased to 95%, blood pressure was still described as low and equal to 82/42.The user facility stated that there has been an issue with bed's footboard - the bed was claimed to be spontaneously turning on pulsatile function and auto instaflating/deflating.In accordance to the information provided by the customer, an arjohuntleigh representative replaced the foot board twice and was able to correct the problem with a properly functioning footboard from another triadyne bed.The individual named in the complaint as arjohuntleigh representative is no longer employed by arjohuntleigh and further information unfortunately cannot be obtained via that person.Review of the repair record related to the bed involved in the event did not show any repair made in area of footboard or bed frame.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for triadyne range we have been able to find one 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 information collected to date, provided problem description and inspection of the device, we have not been able to confirm or recreate the issues claimed by the consumer.The device was inspected by an arjohuntleigh representative who established that the device was in full working condition, no issues have been found.As a part of the device inspection, the bed was kept running for several hours and the alleged issue has not been duplicated.As the re-creation of the issue was not possible, we were not able to establish any possible further root cause of why the issue has occurred in the first place.Please note that to each rented device the quick reference guide (e.G.P/n 308714 rev.A, dated on 03/2014) is attached.It informs the user: how to activate specific functions e.G.Instaflate, rotation or pulsation mode, on the side rail control panels and on the main control panel.How to use air pressure display on the main control panel to view a bar graph representation of air pressures in each section of cushions (head, back, seat, leg).The display also showed a target pressure for cushion section based on manual adjustment made using triangular increase/decrease buttons.That during the patient placement the following check need to be conducted: verification of the pressure setting to allow 40% depression into cushion where patient lied and there is 1 in to 1.50 in minimum clearance below patient's buttocks.It is recommended to lock out the bed functions, and air functions should be used at the staff's discretion to ensure against unintentional operation of system settings.Unfortunately, despite our best effort we were unable to clarify whether the facility staff adjusted the air pressure correctly when placing the patient or whether the mattress function have been locked out by the operator of the device in order to prevent unintentional system operation.Based on the collected information and the fact that the device was in full working condition it seems to be 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 as even although it did not fail to meet its specs, as it did not perform as intended, most likely due to a use error.Fortunately, there were no serious injuries reported.Given the circumstances and the fact that this incident so far appears to be an isolated occurrence, 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
• Manufacturer Contact: pamela wright ; 4958 stout dr; san antonio, TX 78219 ; 2102787040
• MDR Report Key: 4652685
• MDR Text Key: 5606115
• Report Number: 3009988881-2015-00016
• 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: 03/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 308900
• 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