MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. KINAIRMEDSURG

Model Number 201001W

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

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

Event Date 03/09/2014

Event Type  malfunction  

Event Description

Medwatch: 410007000-2014-8010: approx five minutes after placing pt in trendelenburg position for procedure the bed dropped and a large metal piece came flying out from under the bed.Bed was changed immediately.

Manufacturer Narrative

This report is being filed by the mfr arjohuntleigh, inc.Please note that previous medwatch reports for this product may have been submitted from the mfg site kinetic concepts, inc.As of november 2012, complaints related to this product are to be handled by arjohuntleigh, inc.Add'l info will be provided upon conclusion of the mfr investigation.

• Brand Name: KINAIRMEDSURG
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd, ste 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore rd, ste 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3869062
• MDR Text Key: 21311327
• Report Number: 3010048749-2014-00053
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2014

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: Health Professional
• Device Model Number: 201001W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2014
• Initial Date FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 23 YR