MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SMARTPUMP DUAL CHANNEL; TOURNIQUET, PNEUMATIC

Catalog Number	5920011000
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 11 events were reported for this quarter.Product return status 10 devices were received.1 device investigation type has not yet been determined.Additional information 11 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 11 events for the failure: decrease in pressure.1 event had problem identified during non-clinical procedure; there was no patient involvement.8 events had problem identified before clinical use/exposure; there was no patient involvement.2 events had no health consequences or impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99142.Supplemental rationale, corrected data: b5, h6, h11.11 previously reported events were included in this follow-up record.Product return status, 10 devices were received.1 device was not available for evaluation.Evaluation findings (results/components).4 devices: deformation problem / tube.4 devices: no device problem found / part/component/sub-assembly term not applicable.1 device: no findings available / part/component/sub-assembly term not applicable.1 device: electrical/electronic component problem identified / circuit board.1 device: deformation problem / housing.Product disposition.8 devices: serviced and returned to customer.1 device: not repaired but returned to customer.1 device: serviced and put back into stryker stock.1 device: product not received.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between april 1 ¿ june 30, 2025.This report summarizes 11 events for the failure: decrease in pressure.- 1 event had problem identified during non-clinical procedure; there was no patient involvement.- 8 events had problem identified before clinical use/exposure; there was no patient involvement.- 2 events had no health consequences or impact.

• Brand Name: SMARTPUMP DUAL CHANNEL
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22647052
• Report Number: 3015967359-2025-99142
• Device Sequence Number: 15645732
• Product Code: KCY
• UDI-Device Identifier: 07613154589647
• UDI-Public: 07613154589647
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 11
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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
• Device Catalogue Number: 5920011000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown