MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. KINAIRMEDSURG; IOQ

Model Number UNKNOWN

Device Problems Use of Device Problem (1670); Installation-Related Problem (2965)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event not because there was an actual technical malfunction of the device (there was no allegation of that), but since the information received could be interpreted as the device not having performed as intended.When reviewing similar reportable events for devices from the same device range, we have been able to find several similar fault descriptions compared to the situation investigated here, patient fall from the bed.Nevertheless, any repeatable sequence of events have been notice which would be leading to the patient falling out of the device.There is no trend observed for this failure mode.The initial information provided indicated that the product involved in the incident was (b)(4) bed, serial number: (b)(4), which could not be found in our database.The facility has been contacted in order to gather more detailed information regarding the device, however they were not able to identify the type of bed involved, only saying that it was not a (b)(4) bed.Unfortunately, with this unclear information given we were not able to confirm what bed exactly has been involved.The device location was at "the glen at willow valley".The design of the (b)(4) bed is that there are two split safety sides on each side of the bed that provide a barrier from the top of the head section to approximately below the knee, leaving a gap at the foot end of the bed which allows the patient to exit the bed when needed.Please note that side rails should not be disassembled from the device at any time.If the facility staff decide not to use them, they can simply be lowered but will remain attached to the bed frame and used when needed.In accordance to the quick reference guide (#(b)(4) , dated on 08/2014) which is attached to each rental (b)(4) bed, use or non-use of restraints, including side rails, can be critical to patient safety, serious injury or death can result from non-use (potential patient falls) of side rails or other restraints.The decision whether the use of side rails is appropriate should be made based on each patient's needs by the patient and the patient's family, physician and caregivers, with facility protocols in mind.It is recommended that side rails (if used) should be locked in the full upright position when the patient is left unattended.The career should make sure a capable patient knows how to get out of the bed safely in case of fire or emergency.Additionally to minimize the risk of injuries from falls, the patient surface should always be in the lowest practical position when the patient is left unattended.In summary, based on all gathered information we were able to confirm that an adverse event took place, however it remains unconfirmed from which bed the patient has fallen off.As a result of the fall the patient did not sustain any injury, nevertheless we decided to report this complaint based on the potential related with fall and also due to the fact, that arjohuntleigh device may have been used by patient at the time of the event (as initially indicated by the reporter).Upon the performed investigation we were not able to establish any device malfunction that directly could have led to the patient fall.The facility decided to remove the side rails from the bed to be in line with their protocol what resulted in lack of physical barrier for the patient and allow him to rolled out of the bed.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Initially we have been informed by the facility that they had removed the lower side rails from the bed as they are a restrain free facility.However, the patient who was using the bed ended up rolling off the bed onto the floor.The facility enquired if there were any bolster offered for the bed that would be able to help prevent roll-offs.The facility was contacted in order to gather more information from which we were able to concluded: as a result of the fall, the patient did not sustained any injuries the initially indicated model of the involved bed could not be confirmed, however the nurse stated that is was not a (b)(4) the nurse stated that facility will continue to keep the side rails off the bed as per their protocol.

• Brand Name: KINAIRMEDSURG
• Type of Device: IOQ
• 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: 5311065
• MDR Text Key: 33885349
• Report Number: 3007420694-2015-00237
• Device Sequence Number: 1
• Product Code: IOQ
• 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
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/18/2015,07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2015
• Distributor Facility Aware Date: 07/09/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/18/2015
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 12/18/2015
• 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