MAUDE Adverse Event Report: RELIANCE MEDICAL PRODUCTS, INC. RELIANCE MEDICAL PRODUCTS; MODEL 7000 EXAMINATION AND TREATMENT CHAIR

Model Number 7000

Device Problem Unintended Movement (3026)

Patient Problems Wound Dehiscence (1154); Bruise/Contusion (1754); Crushing Injury (1797); Infection, Direct (2244); Cusp Tear (2656)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

This problem was first observed on (b)(6) 2016 by the user facility without any notification to reliance medical products.Reliance medical products was contacted by (b)(6) from the user facility about this problem or event on (b)(6) 2016 and again provided with an update on 04/21/2016.Reliance medical products, inc.Initially requested that the defective membrane in the foot switch be returned, but it was replaced with a new membrane.The defective membrane was discarded.The 7000 exam chair has been corrected for this concern.Also, the user facility has removed this chair from a heavily used patient area.This product in question was over 15 years old with a manufacturing date of october 2000.Device not been returned (replaced).

Event Description

This event or problem below is as described by the user facility: event or problem initially found by user facility on (b)(6) 2016.Event or problem reported to reliance medical products, inc.On 04/14/2016 as follows: (b)(6), biomed technician from (b)(6) contacted reliance medical products that the doctor initially stated, "their 7000 exam chair is raising up without pressing any of the switches randomly", resulting in the chair being raised up on its own.He was notified that this occurrence of the chair raising without requesting it to do so has led to the injury of a male elderly patient.He was told that the patient's top of his hand on his lap was bruised from being pinched / bruised under the slit lamp table as the chair continued to raise on its own.Also, the physician was notified by the patient's daughter that the injured patient's wound opened / skin split and became infected when she returned to the office.Event or problem update reported to reliance medical products, inc.On 04/21/2016: (b)(6), clinical manager of the retinal division response per (b)(6) evaluation: as a precautionary measure (b)(6) replaced the circuit board in the chair but the problem still continued.He removed the foot switch and the chair control cable from the chair and the problem seems to have gone away.This 7000 chair has been removed from service until (b)(6) is able to identify the problem.(b)(6).(b)(6) called reliance medical products back stating, "he found a small piece of a staple oddly punctured through the membrane of the up side of the foot switch".(b)(6) believes that the staple in the up side of the footswitch membrane could have caused the problem.(b)(6) is continuing to test the chair to ensure it is safe to return to service.(b)(6) is working to try to solve the problem.This exam chair has been removed from the heavily used patient area.(b)(6) found a very probable cause of the equipment failure in the foot pedal for the 7000 exam chair.There was a small fragment of metal that made its way into the foot switch pedal and pierced the switch membrane at the exact spot of the elevate button for the exam chair.This would cause the two sides of the switch to be closer together than they should be at rest, thus making it more probable that the slightest movement would cause the chair to rise randomly.I have since changed the membrane in the foot pedal, but have yet to test on the exam chair.

• Brand Name: RELIANCE MEDICAL PRODUCTS
• Type of Device: MODEL 7000 EXAMINATION AND TREATMENT CHAIR
• Manufacturer (Section D): RELIANCE MEDICAL PRODUCTS, INC.; 3535 kings mills road; mason OH 45040
• Manufacturer (Section G): RELIANCE MEDICAL PRODUCTS, INC.; 3535 kings mills road; mason OH 45040
• Manufacturer Contact: mark beismann ; 3535 kings mill road; mason, OH 45040 ; 5133983937
• MDR Report Key: 5653022
• MDR Text Key: 45138516
• Report Number: 1523545-2016-00001
• Device Sequence Number: 1
• Product Code: FRK
• 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
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 7000
• Device Lot Number: 70100002046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 15 YR
• Event Location: Outpatient Diagnostic Facility
• Date Manufacturer Received: 04/14/2016
• 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): Required Intervention