MAUDE Adverse Event Report: ARJOHUTNLEIGH, INC SPIRIT SELECT

Model Number CHGSS1

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

It has been claimed by the facility that: the device's brake was engaged when nurses attempted to pull the pt up in the bed.When they pulled the pt, the bed lurched forward and ran over the nurse's right foot.The nurse went to the emergency room where x-rays were taken and showed that there was no injury.The nurse is doing fine now and is back at work.Mfr ref # 3009988881-2015-00004.

• Brand Name: SPIRIT SELECT
• Manufacturer (Section D): ARJOHUTNLEIGH, INC; 4958 stout drive; san antonio TX 78219 168
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 4420478
• MDR Text Key: 16558837
• Report Number: 1419652-2015-00022
• Device Sequence Number: 1
• Product Code: IKZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CHGSS1
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other