MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. KINAIRMEDSURG; BED, FLOTATION THERAPY, POWERED

Device Problems Detachment Of Device Component (1104); Device Maintenance Issue (1379); Use of Device Problem (1670); Device Operational Issue (2914)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of complaints related to various issue with side rails revealed that there are a few complaints (including this investigated) which concern patient fall due to the side rails failure or side rail detachment.Detailed review revealed that the investigated complaint is the first one with the scenario, where screw became loose due to the constant force applied resulting in side rail detachment and patient fall.The trend for side rail failure mode is decreasing.The product involved in the incident is a kinair medsurge bed, serial number: (b)(4).The device is customer-owned, sold to the (b)(6) care and rehabilitation center.The kinair medsurge system is designed with four side rails: two on each side of the bed.In the down position the side rail fold under the frame.The caregiver can slide the side rails from underneath the frame and rotate the side rails in the upper position.The side rails will lock automatically at half way; in order to continue the elevation of the side rail in the higher position, the caregiver must push the latch again and rotate further until the side rail is locked in the full up position.Upon the device inspection it was found that one of the two bolts that hold side rail detached from the bed frame.Over a time vibration caused by such situation led to wear through the threads of the second bolt.The bold/screw became worn completely smooth and was not holding to the bed frame.Based on the information collected to date and the result of the device evaluation conducted after return of the unit to the service center, we have been able to confirm the alleged malfunction - the screw was loose detaching the right-head rail off the bed frame.It was reported by the customer that a patient fell from kinair medsurge after leaning on the rail over a period of time and in a result the patient suffered a broken femur.According to the customer, the side rails were constantly subjected to physical force from the patient.It was communicated that the patient routinely reposition herself on the bed using the side rails as a support.In such situation the screws come loose or detached due to the repeated force applied on the side rails.The bed was being maintained by a third party company - biomed.The last maintenance was held on 19-aug-2016.No device service history record was provided by the facility.For this reason it is unknown if the third party company verified the device in relation to loose screws.However, it was indicated that biomed company checked the 3 remaining beds owned by the facility after the even to verify the screws.Based on this, it can be assumed that this part of preventive maintenance, which was indicated in internal arjohuntleigh documentation, was not performed previously.User manual # 201500-ah rev.A recommends "that all preventive and battery maintenance procedures be performed only by qualified arjohuntleigh service personnel or arjohuntleigh-approved personnel".In summary, the device failed to meet its specification.A part was worn in a way that would not hold side rail in place causing its detachment.The patient fell from kinair medsurge and in a result suffered a broken femur.The device was used at that time for treatment and therefore did play a role in the event.There are two factors which might contribute to the side rail failure, which resulted in patient fall: constant force applied to the side rails by the patient and incomplete preventive maintenance performed by a third party company.For this reason and taking into consideration all the circumstances of the reported event, the root cause may be defined as use error.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

The patient fell from kinair medsurge after leaning on the rail over a period of time and in a result the patient suffered a broken femur.It was stated that the screw was loose detaching the right-head rail off.The patient had fracture immobilized, administered pain control and applied dvt.

• Brand Name: KINAIRMEDSURG
• Type of Device: BED, FLOTATION THERAPY, POWERED
• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6282307
• MDR Text Key: 65905414
• Report Number: 3007420694-2017-00021
• 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: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 60 YR
• Patient Weight: 87