MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. KINAIR III; BED

Model Number KASK00719

Device Problems Break (1069); Unintended System Motion (1430)

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

Event Date 03/09/2014

Event Type  malfunction  

Event Description

Approximately five minutes after placing patient in trendlenburg positon for procedure the bed dropped and a large metal piece came flying out from under the bed.Bed was changed immediately.

• Brand Name: KINAIR III
• Type of Device: BED
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd ste 308; san antonio TX 78247
• MDR Report Key: 3760761
• MDR Text Key: 22002503
• Report Number: 3760761
• Device Sequence Number: 1
• Product Code: INX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/02/2014

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?: Yes
• Device Operator: Invalid Data
• Device Model Number: KASK00719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR