MAUDE Adverse Event Report: RELIANCE MEDICAL PRODUCTS, INC. RELIANCE MEDICAL PRODUCTS, INC; MODEL 6200 EXAMINATION AND TREATMENT CHAIR

Model Number 6200L

Device Problem Mechanical Problem (1384)

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

Event Date 12/31/2018

Event Type  malfunction  

Manufacturer Narrative

Reliance medical received a complaint alleging a #18 headrest failed on a 6200l model chair.No series injury took place.(b)(6) medical center biomed stated that when pressure is applied the headrest it may collapse backwards.Reliance technical service followed up and in-serviced the customer on proper instructions to ensure the headrest is locked.Reliance technician explained the no.18 headrest is designed so it can be operated with just one hand.To unlock, squeeze the clear plastic actuator into lock housing.This will allow both pivots of the articulating arm to rotate so the headrest can be moved to a new desired position.Once in the new position, release the actuator.Make sure the actuator expands to its original position fully exposing black dot on handle to insure a positive lock.The headrest pad is free to rotate at all times.The customer disposed of the headrest and was unable to provide the headrest back to reliance for further investigation.Reliance is unable to confirm the device failed to meet its specifications and reporting on an alleged malfunction.This complaint will be logged as complaint #(b)(4).The customer has replaced the 6200l model chair with fx920l.The fx920l functions as designed.

Event Description

Reliance medical received a complaint alleging a #18 headrest failed and a patient experienced whiplash.Reliance followed up concerning the allegation of whiplash and the customer did not provide the necessary information to determine the severity of harm of the alleged injury.Reliance does not consider this a serious injury.If any new additional relevant information is identified, the injury will be characterized accordingly.

• Brand Name: RELIANCE MEDICAL PRODUCTS, INC
• Type of Device: MODEL 6200 EXAMINATION AND TREATMENT CHAIR
• Manufacturer (Section D): RELIANCE MEDICAL PRODUCTS, INC.; 3535 kings mills road; mason OH 45040 2303
• Manufacturer Contact: john cummings ; 3535 kings mills road; mason, OH 45040-2303 ; 5133983937
• MDR Report Key: 8603307
• MDR Text Key: 146362381
• Report Number: 1523545-2019-00001
• Device Sequence Number: 1
• Product Code: HME
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/13/2019

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: Health Professional
• Device Model Number: 6200L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 8 YR
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1