MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. KINAIRIV

Model Number 216050

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

It has been claimed by the customer that the patient fell from the bed.Fortunately, the patient did not sustain any injuries as a result of the fall.The event was not witnessed one, therefore the circumstances under which the situation occurred are unknown.The facility has raised the allegation that the bed's exit alarm was not working and the scales needed adjustment.

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

• Brand Name: KINAIRIV
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219 000
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219 000
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste. 308; san antonio, TX 78247-0000 ; 2102787040
• MDR Report Key: 4739992
• MDR Text Key: 5828833
• Report Number: 3007420694-2015-00090
• 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: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/30/2015

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: Other
• Device Model Number: 216050
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/29/2015
• 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