MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. MAXXAIR ETS

Model Number 310800

Device Problems Electrical /Electronic Property Problem (1198); Misconnection (1399); Smoking (1585); Use of Device Problem (1670); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

Initially, it has been claimed that cord wires were exposed and smoking.Based on the additional information provided it has been clarified that no injury occurred as a result of this incident.

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 (under registration #(b)(4)).From november 2012 thru october 31, 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related to complaints of this product were submitted under registration #(b)(4) - as this registration number is no longer valid, reports related to complaints of this product will be submitted under registration #(b)(4).As a consequence of issue with the integration of the former kci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 (b)(4) from november 2012 thru october 31, 2014 medwatch reports related to complaints of this product were submitted.When reviewing reportable events for brand names maxxair and maxxair ets we were able to establish that there was no similar complaints in the past.The issue is considered to be a single, isolated event.The product involved in the incident is a maxxair ets, model number: 310800, serial number: (b)(4), which is a part of arjohuntleigh us rental fleet.We were able to confirm that this bed passed the quality check control on (b)(6) 2014 before it has been placed at the customer side.The faulty device has been returned to the service center and checked.The technician, who worked on this repair, found out that the wires were pulled from the pump and caused the unit malfunction.The technician reattached the wires and fitted a new strain relief.He has also confirmed that there was no heat damage or smoke noticed during the repair, therefore the customer allegation could not be entirely confirmed the damage, as found upon the device return, is most likely related with a customer misuse - when the user is constantly pulling the cord too hard it might result in a loose connection inside the pump socket or a total disconnection of the wires and cause the pump unit to be malfunctioning.The user manual (#310115-ah rev.B for maxxair ets) warns the user about necessity of power cord proper handling procedure: "power cord - position power cord to avoid a tripping hazard and / or damage to the cord.Ensure power cord is kept free from all pinch points and moving parts and is not trapped under casters.Improper handling of the power cord can cause damage to the cord, which may possibly produce risk of fire or electric shock." our initial evaluation of the event based on information available at that time and showed that smoking related with an electrical cord might be a potentially hazardous situation, that could possibly cause a serious injury.Therefore, during that time, the decision was made to report this event to competent authorities based on the potential, in abundance of caution.Further investigation revealed that the customer allegation, regarding the smoking incident, could not be confirmed - there was no sign of any heat damage on the device the situation when wires are exposed is not considered to be safety related as long as there are no additional factors which might create reasonable foreseeable combination of events leading to the hazardous situation in this particular incident, the failure was apparent to the clinical staff, who took appropriate actions and report the failure to the arjohuntleigh representative.The device was taken out of service and repaired.User did not continue to use the faulty device, therefore it appears unlikely that this malfunction would result in an adverse event upon the recurrence.In summary, the device played a role in the event, however it remain unknown if it was used for patient treatment or diagnosis upon the incident occurrence.The device has failed to meet the manufacturer specification, however there was no signs of heat or smoking damage.The root cause of this issue is related with a customer misuse.Given the circumstances and the fact that this complaint is considered to be a single, isolated event, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: MAXXAIR ETS
• 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: 4652100
• MDR Text Key: 17628396
• Report Number: 3009988881-2015-00020
• 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: Risk Manager
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/01/2014

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: 310800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2014
• 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