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

Model Number 209800-R

Device Problems Device Inoperable (1663); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

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 (b)(4).From november 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 (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).We are aware that this is past the 30 day deadline for reporting.The service unit forwarded the information to the manufacturer regarding the failure with a delay due to processing errors.Awareness as well as a review of the fda reporting guidelines has been performed to ensure all future reports are submitted on time.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 chandler regional hospital.Each device need to pass the quality inspection (conduced in accordance to approved work instruction) before being released to the customer for rental period - one of the steps is to verify that all patient straps are in place, undamaged and that the buckles function properly.Device must be in full working condition in order to pass the test and be cleared for dispatch.We have been able to confirm that this device passed the quality control on 2015-12-16, before being placed at the customer facility.In this particular situation the caregiver was not able to open the buckle as it allegedly got tucked up under the edge of proning pack.According to the customer, the patient sustained an oxygen desaturation while being in supine, thus the caregiver decided to cut the strap most likely to gain a full access to the patient.Fortunately, there was no injuries reported as an outcome of this incident.The bed was returned to the service center after the incident occurrence and evaluated by qualified personnel.It has been confirmed that a strap assembly (part number #209088) has been damaged (cut) and required replacement.The user manual (#(b)(4)), 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 - comparable to what happens with a car seat belt.Nevertheless, in this particular complaint due to the fact that the strap was cut thus damaged, upon the return in became impossible to check its functionality to assess whether the initial problem was related with an actual part malfunction or not.The rotoprone device is equipped in two separate, independent systems allowing device rotation: an automatic, electrical rotation and a mechanical, manual rotation.In case an emergency situation should arise both can be used to put the patient into the desire position, either in supine or prone position as needed until the bed could be replaced with a new one or rebooted.In summary, the arjohuntleigh device played a role in the event as it was used for patient treatment.In the customer opinion it has also failed to meet its specification, however based on the limited information we are not able to conclude that the claimed issue was related to an actual device failure, or rather with a customer being not aware of how to disengage the buckle.Although there was no injury sustained 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.

Event Description

Initially, we have been informed that a buckle was broken and patient was stuck on the rotoprone device.Upon the arjohuntleigh technician's arrival, it turned out that the buckle got tucked up under the edge of the proning pack.The customer, instead of raising the issue to the company representative immediately, had cut the strap and raised the issue right after that fact.According to the information provided by the customer, the patient who was placed on the device had a desaturated blood oxygen level while in supine position.Fortunately, there was no injuries reported as an outcome of this incident.

• 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 78247 ; 2103170412
• MDR Report Key: 5696977
• MDR Text Key: 46494652
• Report Number: 3007420694-2016-00096
• 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: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/03/2016,02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2016
• Distributor Facility Aware Date: 02/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2016
• Date Manufacturer Received: 02/08/2016
• 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