MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. TRIADYNE PROVENTA II; IKZ

Model Number 406100

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, it was reported that the triadyne proventa, head cushion was completely deflated.The device was in use at the time of the service call and remained in use while the field sales rep attempted to troubleshoot and ultimately fix the bed.The head cushion was deflated, but hosp staff had placed extra pillows under the patients head to compensate for the lack of support.There was no injury as a result of the device malfunction.

Manufacturer Narrative

-this report is being filed by the mfr arjohuntleigh, inc.Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.As of november 2012, complaints related to this product are to be handled by arjohuntleigh, inc.The device was inspected by field sales rep and repaired at the facility.Upon the device inspection it was found that both of the head cushions were deflated.This section deflation was caused by internal tubing disconnection.The bed in question has a series of connections throughout the bed, to distribute air to different cushions.The hose in question ("yellow" hose due to its markings), first comes up through the frame of the bed from the air box.There is a "quick-connect" port soon after it comes out of the frame, whereby it is possible to detach the hose/cushion system from the bed for cleaning.During the inspection, it was this quick connect that was found to have been disconnected.The reason for the disconnection is unclear.This bed passed the quality check at the service ctr (before device rental), which includes a check of the air surface.The device also passed the on site "pre delivery" quality check at the customer facility.This check also includes a check of the air surface.Because the problem was reported some days after the actual delivery, the issue would likely have been caused during some sort of patient transfer and/or positioning at some point.The device was repaired at the customer facility by reconnecting the internal tubing.Although there was no injury sustained and the hosp staff had placed extra pillows under the patients head to compensate lack of support, we determined that if this type of event were to recur, it may cause or contribute to serious injury.In summary, the device was being used at the time of the event, it failed to meet specification and the tubing disconnection was a direct cause of the complaint, however there was no patient injuries as a result.

• Brand Name: TRIADYNE PROVENTA II
• Type of Device: IKZ
• 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 rd ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4474750
• MDR Text Key: 5323020
• Report Number: 3009988881-2014-00002
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 406100
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 10/29/2014
• 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