MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE

Model Number 209500

Device Problems Device Inoperable (1663); Defective Component (2292)

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

Event Date 07/24/2014

Event Type  malfunction  

Event Description

Initially, it has been claimed that the hinge on the chest pack was stuck and the buckle was not able to be closed.As a result of this failure it was not possible to prone the patient.It is unclear with the limited information provided if the patient sustained any injury as a result of being rotated to the prone position.

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

When reviewing reportable events for the rotoprone device we were able to establish that this complaint is the first reportable one, which covers issue with buckle that could not be locked.There is no trend observed for this issue.The product involved in the incident is a roto-prone bed model number: 209500, serial number: (b)(4).The device is part of the arjohuntleigh us rental fleet.We were able to confirm that this device passed the quality control on 07/16/2014, before being placed at the customer site.Due to the limited information received it was initially decided to report this complaint based on the potential related with a lack of the proning movement, which is considered to a crucial treatment provided by the rotoprone device.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 further review showed that in such situation (buckle cannot be closed) it is ensured per the design that the bed will not start the rotation movement (including proning) as it could lead to the hazardous situation related with patient being not secured and falling from the device.The buckle on the chest pack (one of the proning pack, and subject of this complaint) is electronically monitored- it means that the buckle is not closed, the system will recognize the problem and will not allow the bed to start rotational movement.Additionally, a proper alarm will be shown on the screen to make the caregiver aware about the issue.Therefore a lack of proning movement cannot be considered as a failure and, it should not be seen as a potentially risky situation upon the reoccurrence.The system worked as designed in the situation where the buckle has not been closed.Additionally, it seems that the correct potential hazard related to this kind of failure is customer annoyance resulting from inability to start the rotation, but it is not compromising patient or caregiver safety in any way.The device involved in this incident has been assessed by an arjohuntleigh representative, who visited the customer site, but could not duplicate the claimed issue.Although some parts were replaced before the assessment, none of them could be connected with the problem raised by the customer (replaced parts are part of face pack and the customer claimed issue with buckle on the chest pack).According to user manual (#208662-ah rev b) provided with each device, the caregiver should check the proning pack buckles for wear and verify their proper functionality on the daily basis.If any of the packs or buckles appear to be damaged and require service or replacement, the user is obliged to contact arjohuntleigh.As the circumstances under which claimed failure occurred are unknown it appears plausible that the issue was detected by the caregiver who followed the instruction from the user manual and found the issue during the daily check of the device.Additionally, the rotoprone bed is able to be manually rotated even when an "buckle alarm" present on the control screen.The manual rotation of the bed would enable the caregiver to place the patient in either the prone or supine position as needed until the bed could be replaced with a new one.In summary, the device played a role in the event, however it remains unk if it was used for patient treatment or diagnosis upon occurrence.Based on the performed root cause analysis arjohuntleigh concluded that the claimed issue (buckle which could not be closed) was related either with mechanical failure (release button stuck) or lack of preventive maintenance (debris accumulated in the female end of the buckle) which have led to the temporary, fully detectable failure which was repair by a simple adjustment and did not require a replacement of any part.Although no injury occurred as a result of this event it was initially decided to report it to the competent authorities based on the potential and in abundance of caution.However, based on further analysis of the risk, arjohuntleigh does not see this kind of failures as a reportable events in the future.The risk analysis documentation will be updated in order to reflect this issue properly.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
• 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 rd ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4652096
• MDR Text Key: 20016466
• Report Number: 3009988881-2015-00026
• 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: Nurse
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/24/2014

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: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2014
• 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