MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. KINAIRMEDSURG

Model Number 201001W

Device Problems Device Inoperable (1663); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/13/2014

Event Type  malfunction  

Event Description

It was initially claimed that the bed was not inflating for an injured patient.After multiple unsuccessful attempts to receive additional information and clarify the exact situation, it remained unclear what the patient's outcome was.There was no indication of a serious injury associated with the use of this product however if it were to reoccur it may contribute or cause a serious injury.

Manufacturer Narrative

(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

(b)(4).When reviewing reportable events for the kinair family beds range we were able to establish that this complaint is the 2nd one where an issue with inflation or deflation of the cushions was found to be hazardous for the patient.There is no trend observed for this failure mode.With the complaint at hand we received only an information that the bed is not inflating for the injured patient.Due to the limited information it remains unknown if the issue was related to situation when the bed was malfunctioning and not inflating which resulted in an injury for the patient or if it is just describing situation when the bed could not be used due with the patient due to lack of caregiver training (the patient injury was a preexisting condition).Although none of provided information suggest that an injury occurred in relation to this event we cannot exclude the possibility that during the reoccurrence a serious injury might occur, especially when the description of event is so unclear and the malfunction could not be confirmed.Based on that the complaint was decided to be reportable in abundance of caution, to ensure we are as transparent as possible in our reporting approach.The product involved in the incident is a kinairmedsurg, serial number (b)(4).The device is part of arjohuntleigh us rental fleet.Upon the conducted investigation we were able to confirm that the device passed quality control checks on 01/10/2014 and met specification before being placed in the customer facility.Unfortunately, without having a detailed description of what occurred, we are left to review the limited information received from the customer per our best efforts, and compare it to our product knowledge.The kinair medsurg system is an integrated low air loss therapy support surface that offers advanced skin microclimate management for the prevention and treatment of pressure ulcers.It ensures patient comfort and safety thanks to the adjustable four-zone air suspension system with 10-inch cushion depth which helps reduce interface pressure.Lack of inflation of any bed cushion might be related either with a failure of electrical components (e.G.: blower malfunction) or a failure of mechanical parts (e.G.: hose disconnected, valve motor malfunction).With the provided complaint's description it remained unclear what is the actual subject of this complaint.We were not able to find any related history of repair made on this bed.Moreover, the device has been inspected by an arjohuntleigh representative who confirmed that it was working as per the manufacturer specification - the customer allegation regarding device malfunction has not been confirmed.In quick reference guide for kinair medsurg (#201556-ah rev.B), attached to each device, a description of the bed's features is available as well as instruction of how to use them.The system offers seat deflate setting which automatically lowers the air pressure in the center section of cushions.It also has an instaflate feature with memory return which makes the bed easy to reinflate.Each section of the bed's cushions can be adjusted separately until the patient comfort is reached.Based on all information available, we were not able to establish the exact root cause and sequence of events which have led to the issue covered by this investigation.Having in mind the design of this device and fact that the allegation regarding actual device malfunction has not been confirmed, it seems most likely that the issue raised by the customer was related with incorrectly set air flow, rather than an actual device malfunction.In summary, the device played a role in the event, however it remained unknown if it was used for patient treatment or diagnosis upon the occurrence.The received but not confirmed allegation is that the bed failed to meet the manufacturer specification and was not working as per its design.Due to the limited information available, the exact root cause of this issue could not be established.Given the circumstances and the fact that there is no trend observed for customer complaints with this failure mode, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: KINAIRMEDSURG
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4658 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore rd ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4652086
• MDR Text Key: 5681281
• Report Number: 3009988881-2015-00018
• Device Sequence Number: 1
• Product Code: INX
• 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: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/13/2014

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: Other
• Device Model Number: 201001W
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/13/2014
• Initial Date FDA Received: 04/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2015
• 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