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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RIFTON EQUIPMENT RIFTON ACTIVITY CHAIR

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RIFTON EQUIPMENT RIFTON ACTIVITY CHAIR Back to Search Results
Model Number R870
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2015
Event Type  malfunction  
Manufacturer Narrative
The caregiver did not clasp the chair's seat belt or pelvic harness.The product manual clearly states: "to prevent falls, strangulation, head entrapment or other injuries, always use seatbelt or pelvic harness when the tray, chest straps, thigh belt, mini trunk support, or butterfly harness are in use".
 
Event Description
It was reported that the user was sitting in the chair with the tray in place when the tray latch broke.The caregiver had not clasped the seat belt, so the user fell out of the chair.The user was not hurt.
 
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Brand Name
RIFTON ACTIVITY CHAIR
Type of Device
ACTIVITY CHAIR
Manufacturer (Section D)
RIFTON EQUIPMENT
elka park NY
Manufacturer Contact
travis scott
po box 903
rifton , NY 12471
8456587722
MDR Report Key5001330
MDR Text Key23403589
Report Number1319558-2015-00005
Device Sequence Number1
Product Code INN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Report Date 07/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberR870
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age14 YR
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