MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; IKZ

Model Number 209800-R

Device Problem Defective Component (2292)

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

Event Type  malfunction  

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 #1625774).From november 2012 until 2014 complaints related to these products were handled by arjohuntleigh inc.And any medwatch reports will be submitted under registration #3009988881.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.As a consequence of issues with the integration of the former (b)(4) 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 corrections and corrective actions.Additional information will be provided upon conclusion of the investigation.

Event Description

Initially, we have been informed that the facility staff was not able to open the buckle.With limited information provided it remained unknown under what circumstances the issue occurred and if there was any patient involved.Having in mind that similar failure has resulted with a serious injury in the past, it has been decided to report this event in an abundance of cautions, based on the potential.

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 (b)(4) (under registration # (b)(4)).From (b)(6) 2012 until 2014 complaints related to these products were handled by arjohuntleigh inc.And any medwatch reports will be submitted under registration # (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration # (b)(4).When reviewing reportable events for rotoprone device we were able to establish that there have been similar complaints in the past.There is no trend observed for this failure mode however.The product involved in the incident is a rotoprone bed model number: 209800-r, serial number: (b)(4).The device is part of the arjohuntleigh us rental fleet and has been rented for customer (b)(6) hospital in (b)(6).Upon the conducted investigation we were able to confirm that this device passed the quality control on (b)(6) 2014, before being placed at the customer site.Buckles are used to restrain a patient on the rotoprone when the patient is in supine and prone therapy.The buckle assembly functions much like a seat belt buckle with webbing connected on the right and left side of the bed and a tongue and buckle that get latched in the center of the bed to restrain the patient.The operator of the device is to click together the male and female end of the buckle and tighten the pack straps.Tightness of pack straps will vary according to each patient's needs.Straps need to be as tight as can be tolerated, as patient will shift into the prone packs and away from the patient surface when moved into prone position.Buckle is released by pressing the button inside the buckle.In this particular situation the caregiver was not able to open the buckle and has contacted the company representative in regards to troubleshooting.Unfortunately, with the limited information provided it remained unknown how the issue was solved.The device involved in this incident has been returned to the service center and checked as a part of post placement procedure.It passed all required testing procedure on (b)(6) 2014 and was working as per manufacturer specification post placement.The customer allegation regarding the faulty buckle could not be confirmed (no repairs for this device has been registered).The user manual (#208662-ah rev.2), which is being provided along with each device, contains all crucial warnings, cautions and instruction which should be followed to ensure the patient safety.In the document following information can be found: the instruction how the buckle should be fasten and unfasten.Requirements of daily equipment instruction (including checking the appearance and functionality of the buckle).It is also worth noting that sometimes the buckle being claimed as stuck is not necessarily related with an actual product malfunction.The buckles are designed to keep the patient weight from shifting when the patient is in the prone position.When releasing the buckle hatch, it is sometimes necessary to push down on the patient pack, minimizing the tension of the strap and allow enough slack for the buckle to be opened.In summary, the arjohuntleigh device played a role in the event as it was used for the patient treatment upon the occurrence.Based on the performed root cause analysis arjohuntleigh concluded that the claimed issue was related with a customer being not aware of how to disengage the buckle rather than with an actual device failure.Although none of provided information suggest an injury occurrence as a result of this event it was decided to report it to the competent authorities based on the potential and in abundance of caution.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: ROTOPRONE
• Type of Device: IKZ
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78219 ; 2103170412
• MDR Report Key: 5067042
• MDR Text Key: 25352586
• Report Number: 3007420694-2015-00177
• 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: company representative,user f
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Report Date: 09/10/2015,11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2015
• Distributor Facility Aware Date: 11/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2015
• Date Manufacturer Received: 11/17/2014
• 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