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

Model Number 201001W

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/04/2014

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 product involved in the incident is a kinairmedsurge, model number: 201001w, serial number: (b)(4).The device is part of the arjohuntleigh us rental fleet.The device was rented to the customer ((b)(6) hospital).Each bed in rental fleet need to pass the quality control checks in order to be cleared for dispatch before being placed in the customer facility.One of the requirement of the quality control check for kinairmedsurg bed is to check the movement and functionality of all side rails of the bed, which act as a main protection barrier for the patient.The design of the kinairmedsurg 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.In accordance to the quick reference guide (#409031-ah rev b , dated on 08/2014) which is attached to each rental kinairmedsurg 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 shall 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.Unfortunately, it remained unknown with the limited information provided, whether the facility decided to use the safety side with the patient or not.In summary, based on the investigation performed above we were able to established that there was no problem found with the device that could have led to the patient fall.Therefore, an actual device malfunction could be ruled out.Based on all gathered information it seems most likely that with safety sides being lowered, the patient with reduced body control (due to the preexisting condition; paraplegia) was reaching for something at his side and lost his balance what resulted in an unexpected exit from the bed.Although the device did not fail to meet its specifications, it was being used at the time of the event for patient treatment and due to this played a role in the incident.Complaint was decided to be reportable based on the potential related with fall and to be transparent with the reporting approach.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 that the kinairmedsurg bed deflated and that a paraplegic patient reported to had fallen out of the bed.From additional information provided, we concluded that patient was not injured as a result of the fall.The nurse also stated that there was no allegation of the bed malfunction and that the unintentional exit was unwitnessed one.The nurse also reported that according to the patient, he was reaching for something on the table next to the bed and rolled out onto the floor.

• 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: 5310997
• MDR Text Key: 33880157
• Report Number: 3007420694-2015-00236
• 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: Inspection
• Type of Report: Initial
• Report Date: 12/18/2015,05/05/2014

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: 201001W
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2015
• Distributor Facility Aware Date: 05/05/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2015
• Initial Date Manufacturer Received: 05/05/2014
• 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