MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. SPIRIT SELECT; IKZ

Model Number CHGSS1

Device Problem Low Audible Alarm (1016)

Patient Problem Fall (1848)

Event Date 06/16/2013

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 (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 spirit select beds, we have been able to find couple similar complaints, however there is no trend observed for reportable complaints with this failure for spirit select beds.Based on the information collected to date, provided problem description and inspection of the device, we have not been able to confirm the alleged malfunction.In accordance to the information received from the facility, it is possible that the exit alarm was not turned on and that could explain why the exit alarm did not sound when patient left the bed.After the event occurrence, the bed remained at the facility.Please note that in the user manual for spirit select ( # (b)(4)), the user is informed about the functionality, setting and usage of the exit alarm: the enhanced footboard staff control on the spirit select¿ is equipped with an integral bed exit feature to help monitor and report patient activity with audible and/or nurse/priority call alarms.This feature is not intended to replace patient monitoring by staff.When a patient attempts to exit or does exit the bed (depending upon the zone level selected), the bed exit alarm will be triggered.In summary, upon the conducted investigation we concluded that the device did not fail to meet its specification, however was being used at the time of the event and therefore played role in the incident.We have decided to report this in the abundance of caution based on the provided information that the patient fell from the bed.Given the circumstances and the fact that there is no trend observed, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.(b)(4).

Event Description

On (b)(6) 2013 arjohuntleigh has been informed that alarm did not sound when patient fell out of bed.Arjohuntleigh regulatory representative spoke with the nurse who reported that the patient was not injured.The patient had crawled over the side rail.Nurse stated that she did not think that the bed alarm was on.Unit remained with the customer.The patient was reported as doing well.

• Brand Name: SPIRIT SELECT
• Type of Device: IKZ
• 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: 5864475
• MDR Text Key: 52085393
• Report Number: 3007420694-2016-00169
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/10/2016,06/16/2013

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: Health Professional
• Device Model Number: CHGSS1
• 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: 08/10/2016
• Distributor Facility Aware Date: 06/16/2013
• Event Location: Other
• Date Report to Manufacturer: 08/10/2016
• Initial Date Manufacturer Received: 06/16/2013
• 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