MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. TRIADYNEPROVENTA

Model Number 406000

Device Problems Electrical /Electronic Property Problem (1198); Inflation Problem (1310); Mechanical Problem (1384); Device Inoperable (1663); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2014

Event Type  malfunction  

Event Description

Initially, it has been claimed that the head section of the bed is not inflating and as a result, the patient's head is falling back.From additional information provided by the facility we learned that no injuries have occurred as a result of this event.

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc ((b)(4)).From (b)(6) 2012 thru (b)(6), 2014 medwatch reports related to complaints of this product were submitted under registration #(b)(4) - as this registration number is no longer valid, reports related to complaints of this product will be submitted under registration #(b)(4).As a consequence of issue with the integration of the former kci rental business into arjohuntleigh and challenges from i.E.It perspective we were forced to a more manual process to screen service data for complaints.We have realized that this process did not detect all complaints and that arjohuntleigh have failed to get them all timely into our complaint handling system.Unfortunately, as a result of a retrospective review after this finding we have identified this reportable complaint that is filed late.As a consequence of the complaint being old we have limited information on the event while additional effort to obtain data has been performed.We will continue our efforts to complete this investigation.A capa has been initiated to document the efforts to complete investigations, and implement corrects and corrective actions.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc.From november 2012 thru october 31, 2014 medwatch reports related to address complaints of this product were submitted.When reviewing reportable events for the triadyne proventa and triadyne ii brand names we were able to confirm that this is the 2nd complaint, initially assessed as reportable, related with an issue of the head section inflation/deflation process.Upon review of standard complaints for those brand names we were able to find a number of additional records related to issue with deflation of the head section.In none of found complaints we were able to find an indication of a person sustaining any injury due to the claimed failure.There is no trend observed for this failure mode.The product involved in the incident is a triadyneproventa bed, model number 40600, serial number: (b)(4).The device is part of arjohuntleigh (b)(4).The device was rented to the customer (b)(6) medical center in.We were able to confirm that this bed passed the quality check control on 25th of july 2014 before it has been placed at the customer side.With the complaint at hand, we received an information that the head section of the bed was not inflating and the patient's head was falling back.No injuries were reported in relation to this issue.Based on the initial statement from the customer and information provided with the current risk analysis documentation, the decision was made to report this complaint to competent authorities based on the potential and in abundance of caution.Nevertheless, as a part of the investigation for this event, the further evaluation of the risk related with a head cushion deflation was conducted.The performed investigation revealed in finding that such deflation of the head section of the triadyne family range bed would be unlikely to cause or contribute to death or serious injury - the deflation of the head section is not rapid and is not causing the patients head to be jarred or impacted against the bed surface.The failure is easy to noticed by the device operator who is acting correctly by raising the issue to the service unit.The device is an acute care bed that would necessitate patients being very closely monitored, depending on their diagnosis or condition patients at greatest risk would be intubated and intubated patients are very closely monitored.Please note that at the complaint at hand there is no information suggesting that the patient was intubated.Moreover, the deflation action is controlled by the use of flow valve and in the event of the air cells becoming disconnected the port sizes of the connectors are causing slow and gentle deflation, preventing any sudden impact to the patient's head.The triadyne proventa system include a low air loss therapy mattress.The pneumatic distribution in the mattress is related to the valve assembly (valve block) and a blower.There are 8 valves and 8 mechanical motors in the valve block, each one operating independently of the other.The valve assembly is controlled by a microprocessor located in the master control board and it can open or close the valves based on the pressure settings.For the problems with over inflated or under inflated cushions the most likely root cause is a failure of the valve block, especially the valve motor, since those parts are responsible for allowing more or less air to flow into the bed cushions, based on the settings adjusted by the user.The technician who inspected the involved device found that the valve motor for the head section was not working and needed a replacement.After the replacement of the faulty part the bed was working according to the manufacturer specification.The root cause of this failure is confirmed to be a faulty valve motor.Whilst there is no doubt that the product has failed to meet its specifications - the head section deflation - it was noticed by the user who took the appropriate action in reporting the failure of the device.The user is not likely to continue the use of the device after detecting the failure.Due to the reasons mentioned above, it appears not likely that this malfunction can result in an adverse outcome upon recurrence.In summary, when the event occurred, the device was being used for the patient treatment, therefore it played a role in the event performed evaluation of the involved bed allowed to establish that it failed to meet the manufacturer specification and was not working as per its design.Although no injury occurred as a result of this event it was initially decided to report it to the competent authorities based on the potential and in abundance of caution.However, based on the further analysis of the risk, arjohuntleigh does not see this kind of failures as a reportable events in the future, as long as they are concerning the head section deflation only and there are no additional factors leading to hazardous situations (such as unrelated inappropriate / off-label use).The risk analysis documentation will be updated in order to reflect this issue properly.Given the circumstances and the fact that there is no trend observed for this failure mode arjohuntleigh does not propose any other action at this time.

• Brand Name: TRIADYNEPROVENTA
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4985 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore rd ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4652076
• MDR Text Key: 5597349
• Report Number: 3009988881-2015-00028
• 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,user facility
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 406000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2014
• 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): Other