MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. SPIRIT SELECT

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been claimed by the facility that the pt fell out of the bed, fortunately pt was not injured.The event was un-witnessed.There is also an allegation that the exit alarm of the device was not working.Mfr ref#: 3009988881-2015-00015.

• Brand Name: SPIRIT SELECT
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout dr; san antonio TX 78219
• MDR Report Key: 4619911
• MDR Text Key: 5594086
• Report Number: 1419652-2015-00091
• 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: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2015

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: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1