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U.S. Department of Health and Human Services

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

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ARJOHUNTLEIGH INC. SPIRIT SELECT; IKZ Back to Search Results
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.
 
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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 Key5864475
MDR Text Key52085393
Report Number3007420694-2016-00169
Device Sequence Number1
Product Code IKZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberCHGSS1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/10/2016
Distributor Facility Aware Date06/16/2013
Event Location Other
Date Report to Manufacturer08/10/2016
Initial Date Manufacturer Received 06/16/2013
Initial Date FDA Received08/10/2016
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 Number1
Patient Outcome(s) Other;
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