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	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A weld on part e7130 failed while the table was in use.There was no injury, however the doctor's floor was damaged.

• 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: 19629993
• Report Number: 3007278668-2024-00003
• Device Sequence Number: 8673647
• Product Code: ITH
• UDI-Device Identifier: 00850008449826
• UDI-Public: 00850008449826
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Recall
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: 06/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 94815
• Patient Sequence Number: 1
• Patient Sex: Unknown