MAUDE Adverse Event Report: OSTEOMED, LLC BMF FOOTSWITCH

Model Number 450-0390

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This information was provided to osteomed/acumed by the user in response to the customer notification received as a part of recall number: 2027754-10/22/21-r.The customer is not returning the device as they elected on the medical device recall return response form that they will be disposing of the recalled device at their facility.As reported by the user, the event date is unknown, they had returned the footswitch for service and at that time it was determined the footswitch would not work due to the split in the cord.

Event Description

On 16 december 2021, the customer called in as a result of recall number: 2027754-10/22/21-001-r, and the customer reported they previously had "electrical issue", and that "it started with a cord being split or cut.Osteomed repaired the product and sent it back." additionally, the customer stated "the spring pedal would get stuck and the console wouldn't work".Follow up was conducted to obtain more information, and on 17 january 2022 the facility was able to be contacted and clarified the pedal would sometimes not work (event date unknown), so the facility had returned the pedal to the osteomed service team and it was determined the cause was because the cord was split on the pedal.Per the facility, there were no adverse consequences to the patient, and no delay during the procedure.

• Brand Name: BMF FOOTSWITCH
• Type of Device: BMF FOOTSWITCH
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: elhum wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 13266983
• MDR Text Key: 294130934
• Report Number: 2027754-2022-00007
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 450-0390
• Device Catalogue Number: 450-0390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• 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
• Removal/Correction Number: 2027754-10/22/21-R
• Patient Sequence Number: 1