MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE

Model Number 209800-R

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

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.When reviewing reportable events for rotoprone devices 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 medical center of (b)(6).Each device needs 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.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.A technician who visited the customer stated that buckle was stuck due to the material of the chest pack being trapped into the buckling mechanism.Based on our product knowledge such situation can occur only if the customer is trying to close the buckle when the strap is tightened.In the situation like that a distance between the female and the male part of the buckle is increased, thus in order to attach them together the customer must squeeze the pack and that can cause a part of material to get into the buckle, preventing it from easy reengaging when needed.The user manual (#208662-ah rev.C), 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.How the chest pack should be adjusted (including tightening of the strap).It is worth noting that in case of chest pack, while placing the patient the pack should be only buckled and after the patient is placed into the prone position a strap should be tightened, as indicated in the user manual.Requirements of daily equipment instruction (including checking the appearance and functionality of the buckle).In summary, the arjohuntleigh device played a role in the event and failed to meet it specification, however it remained unknown if 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 how to correctly engage the buckle.Due to this fact, a material of the chest pack got trapped into the buckling mechanism resulting in inability of disengaging the buckle when needed.Although none of the provided information suggests 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.

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.The company representative, who was visiting the customer in order to check the device stated that the buckle and strap needed to be replaced, however, it remained unknown how exactly were these parts damaged.Having in mind the possibility that a reason for strap replacement could have been related with this part being cut in the process of patient handling procedure and by the fact that there is a possibility of the actual adverse outcome if the event would to reoccur, it has been decided to report this event based on the potential and in abundance of cautions.

• Brand Name: ROTOPRONE
• Type of Device: ROTOPRONE
• 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: 5191259
• MDR Text Key: 30124992
• Report Number: 3007420694-2015-00205
• 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: 10/30/2015,05/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2015
• Distributor Facility Aware Date: 05/24/2014
• Date Report to Manufacturer: 10/30/2015
• Date Manufacturer Received: 05/24/2014
• 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