MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. KINAIRMEDSURG; INX

Device Problems Collapse (1099); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

It has been claimed by the facility that the bed was broken - the facility's nurse stated that they just lifted the frame to its highest position and all of a sudden it just fell.The bed collapsed.Additionally, the information, that someone was working on something underneath the bed and it fell has been provided.No information about injury has been received.No more detailed description of the event is currently available.

Manufacturer Narrative

(b)(4).This submission provide also a correction of brand name, which was initially incorrectly identified.Previous: kinairiv, current: kinairmedsurge.When reviewing similar reportable events for kinair family range, we have found one similar fault description compared to the situation investigated here: bed dropped/collapsed related with use of the "trendelenburg" function.There is no trend observed for reportable complaints with this fault scenario for kinair devices.One of the device's features is the ability to move the patient surface into the "trendelenburg" or reverse "trendelenburg" position.In order to use these functions, the operator of the device shall follow the guidance provided in the product labeling (e.G.User manual #201500-ah rev.A or quick reference guide #201556-ah rev.B) which are delivered to the customer together with the device.Trendelenburg levers are located on the foot end of the bed's frame.In order to activate these functions the operator need to raise the device to the full height position.Then one of the levers needs to be pulled, in order to request "trendelenburg" or reverse "trendelenburg" feature.To adjust the patient support surface from 0 to 8 degree "trendelenburg" or reverse "trendelenburg" position, the bed's "down" function is to be used.Additionally, there is a label placed on the device, just above the trendelenburg knobs indicating how to use these device functions: raise bed completely; pull desire lever; lower bed to position; to disengage, raise bed.Based on the information collected to date, provided problem description and inspection of the device conducted by an arjohuntleigh representative, we have not been able to confirm if the device actually collapsed or it moved rapidly in down direction within its normal range.Nevertheless, as the device was in its normal height at the time of technician's inspection and it was working as intended (except broken "trendelenburg" knobs, no damages to the frame has been found, no loose parts or screws), it seems more likely that there was no actual collapse of the bed but it had rather lowered rapidly - within the device's range movement.The components which broke off were "trendelenburg" knobs, it seems that both of them were pulled at the same time, which cause the bed to become stuck.The facility staff attempted to repair the device by adjusting the bed (likely by forcing the knobs back to their original positions).Unfortunately, we were not able to clarify and identify with certainty if the adjustment of the bed made by an unqualified person resulted with breaking of the knobs, leading further to bed moving down or it cause the patient platform to drop to down position which resulted with breakage of the knobs.Nevertheless, it is recommended to provide the retraining session to the facility, keeping attention to proper use of trendelenburg function as well as to inform the customer that all repairs/service activities shall be made by properly trained and qualified personnel, therefore it is highly recommended to contact the arjohuntleigh service unit, in case of any device breakdown.In summary, the device was being used at the time of the event, it failed to operate as intended as it suffered a malfunction due to a use error - improper use of trendelenburg function and attempt to repair the device by unauthorized personnel, and in doing so it contributed to the outcome of the event - bed dropped, moved rapidly in the down direction.Fortunately, there were no injuries sustained as a result.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.

• Brand Name: KINAIRMEDSURG
• 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: 5113055
• MDR Text Key: 27312228
• Report Number: 3007420694-2015-00187
• 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: company representative,user f
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Followup
• Report Date: 10/28/2015,09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2015
• Distributor Facility Aware Date: 09/01/2015
• Event Location: Other
• Date Report to Manufacturer: 10/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• 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