MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. KINAIRMEDSURG

Model Number 201001W

Device Problems Detachment Of Device Component (1104); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

Initially, it has been claimed that a side rail fell off the bed on the foot patient's family member.Fortunately, there were no injuries sustained as a result of this event.Additionally, it has been claimed that the turning function was not working correctly.

Manufacturer Narrative

As a consequence of issue with the integration of the former (b)(4) into arjohuntleigh and challenges from i.E.It perspective we were forced to a more manual process to screen service data for complaints.We have realized that this process did not detect all complaints and that arjohuntleigh have failed to get them all timely into our complaint handling system.Unfortunately, as a result of a retrospective review after this finding we have identified this reportable complaint that is filed late.As a consequence of the complaint being old we have limited information on the event while additional effort to obtain data has been performed.We will continue our efforts to complete this investigation.A capa has been initiated to document the efforts to complete investigations, and implement corrects and corrective actions.Additional information will be provided upon conclusion of the investigation.

• Brand Name: KINAIRMEDSURG
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore rd ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4652098
• MDR Text Key: 19306761
• Report Number: 3009988881-2015-00022
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 201001W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other