MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. KINAIR MEDPULSE; INX

Model Number 40900

Device Problem Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Type  malfunction  

Manufacturer Narrative

This appears to be a "malfunction" type of event not because there was an actual technical malfunction of the device (we found no evidence of it), but since the information received could be interpreted as the device not having performed as intended.When reviewing similar reportable events for the device family range, we have been able to several adverse events that covers problem with patient falling put of the bed due to the various reasons.No trend is observed for this failure.The product involved in the incident is kinair medpulse bed, serial number: (b)(4), model number: 409000.The bed was a customer owned one and has been delivered on (b)(6) 2013.Upon the conducted investigation, we deemed the root cause to be related to user error.The patient was attempting to move from the bed into a wheelchair by himself and had fallen.The patient had been instructed not to enter or exit the bed without assistance.The bed was not evaluated by a field repair technician as there was no allegation of product malfunction.The product user manual (e.G.: #409100-ah rev a) provides detailed instructions for use and caregivers are advised to read all chapters of the manual prior to product use.The manual contains sections designating indications for use, contraindications, precautions and safety tips as well as detailed instructions for use.In summary, the device did not fail to meet its specifications, however it was being used at the time of the event for patient treatment, and due to this played a role in the incident.Although there was no injuries sustained as a result, it was decided to report this complaint based on the potential related with patient fall and to be transparent with our current reporting approach.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, arjohuntleigh has been informed that patient fell from the bed during an attempt to get in or out of the device.From additional information gathered, we were able to establish that no injuries occurred as a result of this event.The initial reporter clarified that there was no allegation regarding device malfunction as cause of the patient unfortunate fall.The patient was attempting to get into the bed from his wheel chair by himself and fell during the process.The patient had been instructed not to get in or out of the bed without assistance.

• Brand Name: KINAIR MEDPULSE
• Type of Device: INX
• 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 78247 ; 2103170412
• MDR Report Key: 5864431
• MDR Text Key: 52740399
• Report Number: 3007420694-2016-00165
• Device Sequence Number: 1
• Product Code: INX
• 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: Notification
• Type of Report: Initial
• Report Date: 08/10/2016,02/05/2013

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: 40900
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2016
• Distributor Facility Aware Date: 02/05/2013
• Event Location: Home
• Date Report to Manufacturer: 08/10/2016
• Initial Date Manufacturer Received: 02/05/2013
• Initial Date FDA Received: 08/10/2016
• 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