MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. KINAIRMEDSURG

Model Number 201001W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 02/11/2015

Event Type  malfunction  

Event Description

It has been initially claimed by the customer that during the weekend the pt had fallen out of the bed due to the siderail being defective and not latching properly.As a result of the fall, the pt had a bump on his head.Regardless of the outcome of this fall, it has been confirmed that pt did not require any med intervention or treatment.

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the mfg site kinetics concept inc (under registration number 1625774).From november 2012 to october 31 2014 medwatch reports related to complaints of this product were submitted under registration number 3010048749.Since this registration number is no longer valid, reports related to complaints of this product will be submitted under registration number 3009988881.With the complaint at hand, it has been indicated by the customer that during the weekend the pt had fallen out of the bed due to the side rail being defective and not latching properly.As a result of the fall, the pt did not require any med intervention or treatment.As the event was not witnessed by anyone we do not know the exact circumstances under which the failure occurred.It is unk if the pt fell down when turning from one side of the bed to the other.The arjohuntleigh service rep, who has inspected the involved device, was not able to find any problem with the bed.In summary, when the event occurred, the device was being used for pt treatment; therefore, it played a role in the event (pt had fallen from the device).Performed eval of the involved bed allowed us to establish that it did not fail to meet the mfr specification and was working as per its design.The exact sequence of events that led to the fall have remained unk due to the limited info provided.Given the circumstances and the number of similar events, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: KINAIRMEDSURG
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout dr; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout dr; san antonio TX 78219 000
• Manufacturer Contact: pamela wright ; 12625 wetmore rd ste 308; san antonio, TX 78247-0000 ; 2102787040
• MDR Report Key: 4611587
• MDR Text Key: 18919154
• Report Number: 3009988881-2015-00014
• 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: User Facility,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 201001W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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