MAUDE Adverse Event Report: CONMED LARGO BEACH CHAIR SHOULDER POSITIONING SYSTEM; APPARATUS, TRACTION, NON-POWERED

Catalog Number 9880

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 07/03/2023

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of the customer that the device 9880, beach chair shoulder positioning system, was being used on (b)(6) 2023 during an unknown procedure when it was reported ¿after using it for about 4 hours to fix the head, the patient showed symptoms of nerve compression.¿.Further assessment found that no further information was available for this incident.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient showing symptoms of nerve compression.

Event Description

The distributor reported on behalf of the customer that the device (b)(6), beach chair shoulder positioning system, was being used on (b)(6) 2023 during an unknown procedure when it was reported ¿after using it for about 4 hours to fix the head, the patient showed symptoms of nerve compression.¿.Further assessment found that no further information was available for this incident.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient showing symptoms of nerve compression.

Manufacturer Narrative

Update: in section d4 the device serial number was updated from (b)(6).Manufacturer narrative: the device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed, and no data was found.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device failure mode.During this same time frame 6 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.2 per the instructions for use, the user is advised that when the patient is placed in the beachchair, the headrest should be adjusted to fit the patient.The patient's head should rest comfortably in the bottom of the horseshoe-shaped headrest.There are two adjustments for this purpose.The extension pad can be inserted to tilt the patient's head forward to correct hyperextension of the neck (figure 4).Two headrest adjustment pins allow the headrest to be adjusted for height.To change the height of the headrest, both pins must be pulled out while sliding the headrest up and down.The pins can be locked in an out position to facilitate the adjustment.However, both pins must click into a locked position after the adjustment.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: BEACH CHAIR SHOULDER POSITIONING SYSTEM
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17423327
• MDR Text Key: 320026076
• Report Number: 1017294-2023-00070
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10845854026236
• UDI-Public: (01)10845854026236(11)160921(30)1(10)779693
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic