MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. SPIRIT SELECT

Model Number CHGSS1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Skin Tears (2516)

Event Date 03/17/2015

Event Type  malfunction  

Event Description

Initially it has been claimed by the facility that the patient got out of the spirit select bed and fell.The exit alarm reportedly did not sound at that time.Additionally, the provided information revealed that the patient had parkinson's disease and dementia.He got out of bed, to go to the bathroom and did not use his walker.He walked about three or four feet and then his legs locked up and he fell to the floor.The rn that came into the room, after hearing him yell, said the bed alarm had not indicated that he had left the bed.Patient, (b)(6) years old male, weighing (b)(6) suffered minor skin tears to knee and thigh.As for a treatment bacitracin was prescribed and the wound dressing was applied.The patient did not go to the emergency room, the patient's hospitalization has not been prolonged due to this event.

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc.From november 2012 medwatch reports related to complaints to this product will be submitted.This appears to be a "malfunction" type of event (h1) 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 two similar fault description compared to the situation investigated here: patient fell from the bed.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 patient's family, who was visiting him prior to the event, had reset the exit alarm after putting patient back into the bed.This could explain why the exit alarm did not sound when patient left the bed.In summary, the device did not fail to meet its specification, was not being used at the time of the event and therefore did not play a role in the incident.We have decided to report this based on the initial information and in the abundance of caution based on the provided information that the patient fell from the bed.After conducting our investigation it has been clarified that the patient fell when going to the bathroom without his walker.The bed exit alarm was in question however we have found no evidence of any malfunction.Given the circumstances and the fact that this incident appears to be a remote one, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: SPIRIT SELECT
• 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 rd; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4680271
• MDR Text Key: 20788562
• Report Number: 3009988881-2015-00033
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CHGSS1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2015
• 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
• Patient Age: 76 YR
• Patient Weight: 75