MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. SPIRIT SELECT

Model Number CHGSS1

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

It has been indicated by the customer that the patient had laid over a night directly on the bed frame.The device has been delivered to the facility on (b)(6) 2014, at 3:52p.M the customer state that the bed was never plugged in by the technician.The service consultant who delivered the spirit select bed with fist step select mattress on it, state that he assisted the hospital's technician in wheeling the bed into the patients room.The bed was plugged in, turned on, patients height/weight parameters has been set and the devices were in working order while the service consultant was present.At that time, the patient was on another bed and has not been transferred to the spirit select bed while the service consultant was present.The device delivery has been signed off by the unit secretary.Patient has been described as having serious medical condition, that needed the therapeutic surface.

Manufacturer Narrative

This report is being filed by the manufacturer arjohuntleigh, inc.Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.Additional information will be provided upon conclusion of the manufacturer investigation.

• Brand Name: SPIRIT SELECT
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore road, suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore road, suite 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4102047
• MDR Text Key: 4756133
• Report Number: 3010048749-2014-00080
• 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
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/15/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: CHGSS1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 09/15/2014
• 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