MAUDE Adverse Event Report: PIVOTAL HEALTH SOLUTIONS, INC. BENCHMARK; EXAM TABLE

Model Number E9142

Device Problem Mechanical Problem (1384)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Date 02/08/2023

Event Type  Injury  

Event Description

It was reported that a female patient sat on the lower third of a benchmark model e9142.The patient reportedly placed herself on the edge of the table without being directed to sit there and without assistance and then she fell off the table and was injured.It was reported that it was not known how the patient came to fall off the end of the table but the table was not broken, did not require repair after the incident, and continued to be used at the clinic after the incident.

Manufacturer Narrative

It was described that the patient had sat on the lower third section of the table that iis not intended to be sat on and that the patient placed herself there without being directed to do that.It was also reported that the table was not broken, did not require repair after the incident, and that the table continued to be used after the incident.It was not determined how the patient came to fall off the table.The device is 13 years old, the model has not been manufactured in approximately 10 years, and the investigation did not find any indication that the table broke, malfunctioned, or in any way contributed to the incident.The table continues to be used in the same clinic to today.

• Brand Name: BENCHMARK
• Type of Device: EXAM TABLE
• Manufacturer (Section D): PIVOTAL HEALTH SOLUTIONS, INC.; 3003 9th ave. sw; watertown SD 57201
• Manufacturer Contact: julee driver ; 3003 9th ave. sw; watertown, SD 57201 ; 6057530110
• MDR Report Key: 17760757
• MDR Text Key: 323552893
• Report Number: 3007278668-2023-00001
• Device Sequence Number: 1
• Product Code: INW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E9142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female