MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE

Model Number 209800-R

Device Problem Device Inoperable (1663)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

The following was reported by the arjohuntleigh field repair technician: upon post placement eval, it was determined that the emergency release lever was inoperative.The drive belt, was replaced and then tested.After repair, the bed passed quality control (qc) checks and met specification.There was no injury to the pt.This is being reported in an abundance of caution as if this type of malfunction were to recur it may cause or contribute to death, serious injury or medical intervention to prevent harm.

Manufacturer Narrative

This report is being filed by the bfr arjohuntleigh, inc.(registration # (b)(4)).Please note that previous medwatch reports for this product may have been submitted from the mfg site kinetic concepts, inc.(under registration # (b)(4)).As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.And registration # (b)(4).If add'l info becomes available the complaint will be re-opened, assessed for reportability and a supplemental report will be submitted.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd; suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore; ste 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 3824049
• MDR Text Key: 21878946
• Report Number: 3010048749-2014-00007
• 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: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1