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	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the manufacturer to report that as they were uncrating the table and were in the prcoess of moving the table, the lumbar section of the table was observed as not being horizontal and level with the other cushion sections, it was tipped downard.Pictures were sent by the customer to the manufacturer and it was determined that there may be a partial weld break and the immediate decision was made to have the table shipped back to the manufacturer.There was no patient contact with the device.

• 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: 19342108
• Report Number: 3007278668-2024-00002
• Device Sequence Number: 8966425
• Product Code: ITH
• UDI-Device Identifier: 00850008449826
• UDI-Public: 00850008449826
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 05/17/2024
• 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