MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM SMART OCCLUDER; TUBE CLAMP

Model Number	QSOR
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Loaner occluder that was sent in response to fon #(b)(6) stopped responding to open/close commands from the qws.Reportees are unsure if there was a "no occluder location" message at the time of this event.The occluder was also reported to "eventually start working" again.Issue occured approx.1000 prior to a case.Recommendation was given to try a new cable and then a new port on the frame if the cable was damaged from the frame.No further information.Same rep contacted again around 1700 stating as biomed attempted to download logs for the issue above, only the qws would boot up and not the rest of the submodules.Rest of the pump was turned on via the solaris power button but pump manager was not present.Sap cable was unplugged from the qws and replugged in but pump manager was still not present.Qws was then turned off with a long press, then sap cable unplugged again and replugged in.Upon boot up pump manager came back.Medtronic rep was on facetime with biomed and verifies that solaris was plugged into the wall during this time.He also sent a picture of a qws with a green power led in the bottom right instead of blinking blue, suggesting that the hlm was plugged into the wall.
Additional Manufacturer Narrative
System logs were reviewed.Spectrum medical has improved in the latest occluder sw build the occlusion profile, which improves full occlusion and eliminates the potential for the occluder to relax during the late stage of closing.The latest occluder sw build loaded on the network.Account rep confirmed that no issues have occurred since the update to occluders.

• Brand Name: QUANTUM SMART OCCLUDER
• Common Device Name: TUBE CLAMP
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: asia lukuc ; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 21264089
• Report Number: 3006073153-2025-00015
• Device Sequence Number: 9646659
• Product Code: DTQ
• UDI-Device Identifier: 05060434421944
• UDI-Public: 05060434421944
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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: QSOR
• Device Catalogue Number: 51-000074-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 01/29/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown