MAUDE Adverse Event Report: UNKNOWN; STIRRUP FOR BED ASSEMBLY

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2015

Event Type  malfunction  

Event Description

Dr was moving the patient's left leg, which was in a stirrup.As dr moved, the entire stirrup came out of the bed attachment and started to fall.Patient's leg never left doctor's hands so no injury to the patient.Maintenance was called to check on the problem and found no problem.There is a quick release for the stirrup assembly that was accidentally bumped.No equipment problem.It was a human factor/user error.There is a quick release for the stirrup assembly that was accidently bumped.

• Type of Device: STIRRUP FOR BED ASSEMBLY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5328883
• MDR Text Key: 34404778
• Report Number: 5328883
• Device Sequence Number: 1
• Product Code: HDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR