MAUDE Adverse Event Report: SKYTRON LLC SKYTRON; TABLE, OPERATING-ROOM, AC-POWERED

Model Number GS70

Device Problems Break (1069); Product Quality Problem (1506); Failure to Recalibrate (1517); Device Sensing Problem (2917); Unintended Movement (3026)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

In 2021, bwh purchased 3 skytron gs70 salus or tables to be used in the gyn service.These tables were put into service on march this year.In (b)(6), bwh received a report that one of these tables was damaged during room turnover.An operating room assistant used the level function to return the table to a level position, but the back section of the table continued to lower beyond a level position causing damage to the back section.Upon inspection, biomed found that the hand control was displaying an incorrect back section angle.For example, when the back section was at a level position (i.E., 0°), the angle displayed on the hand control was 24°.The level function returned the back section to what it ¿thought¿ was 0°, which explained why the back section continued to lower beyond an actual level position.This sudden miscalibration seemed to have happened spontaneously.The week prior to the go-live, bwh biomed observed a similar phenomenon with a different gs70.In that case, the problem resolved itself in the time it took (approximately 2 days) for the vendor to come onsite to recalibrate the sensor, so we did not take further action at that time.After the april event, bwh removed all 3 gs70s from service and sent the 2 affected tables to skytron for investigation.In (b)(6), skytron responded, attributing the issue with the first table to routine failure of the potentiometer sensor that measures the back section angle.The investigation into the other table was inconclusive.Skytron sent us 2 new gs70s to replace the ones we sent out for investigation.After receiving skytron¿s reassurance that this issue was caused by a routine and unfortunately timed hardware malfunction, we decided to put our 3 gs70s back into service in (b)(6).Then, in (b)(6), another report of table damage during leveling of a table was reported to bwh biomed.We confirmed the same issue had recurred in one of the new replacements gs70s.In september, while checking the other gs70s, bwh biomed discovered also had a miscalibrated back section.All 3 gs70s were removed from service and sent to skytron for investigation.

• Brand Name: SKYTRON
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): SKYTRON LLC; 5085 corporate exchange blvd se; grand rapids MI 49512
• MDR Report Key: 15671493
• MDR Text Key: 302401780
• Report Number: 15671493
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GS70
• Device Catalogue Number: GS70
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1