MAUDE Adverse Event Report: PIVOTAL HEALTH SOLUTIONS DECOMPRESSION OF CHOICE; DECOMPRESSION TABLE

Model Number	E9011
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was uncrating the product and moving the device when the lumbar end of the table was identified as being loose.When the device continued to be moved the doctor determined that the lumbar adjustment section of the device was hanging low instead of horizontal and at that time the customer could see between the lumbar and thoracic cushions that a weld had been compromised on the frame.The customer contacted pivotal health solutions and sent a picture and pivotal health solutions was able to verify that a weld had failed and then took immediate action to have the table returned to the manufacturer.There was no patient use on this device.
Event or Problem Description
The weld on the lumbar section of the table failed.

• Brand Name: DECOMPRESSION OF CHOICE
• Common Device Name: DECOMPRESSION TABLE
• Manufacturer (Section D): PIVOTAL HEALTH SOLUTIONS; 3003 9th ave. sw; watertown SD 57201
• Manufacturer (Section G): PIVOTAL HEALTH SOLUTIONS; 3003 9th ave sw; watertown SD 57201
• Manufacturer Contact: julee driver ; 3003 9th ave. sw; watertown, SD 57201 ; 6057530110
• MDR Report Key: 19336621
• Report Number: 3007278668-2024-00001
• Device Sequence Number: 6519152
• Product Code: ITH
• UDI-Device Identifier: 00850008449826
• UDI-Public: 00850008449826
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K101889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: E9011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3007278668-5/17/24-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown