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

Model Number	5920011000
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 15 malfunction events, in which the device reportedly had a decrease in pressure.15 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 15 events were reported for this quarter.Product return status: 6 devices were received.2 devices were not available for evaluation.7 device investigation types have not yet been determined.Additional information: 15 devices were not labeled for single-use.15 devices were not reprocessed or reused.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h6, h10 15 events were originally reported for this failure mode during the reporting quarter; however, - 1 event was inadvertently excluded.- 16 reported events are included in this follow-up record.Product return status 10 devices were received.3 devices were not available for evaluation.3 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 16 malfunction events in which the device reportedly had a decrease in pressure.- 2 events had no patient involvement; no patient impact.- 14 events had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 16 malfunction events in which the device reportedly had a decrease in pressure.2 events had no patient involvement; no patient impact.13 events had patient involvement; no patient impact.1 event had insufficient information received.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.16 previously reported events are included in this follow-up record.Product return status: 12 devices were received.3 devices were not available for evaluation.1 device investigation type has not yet been determined.
Event or Problem Description
This report summarizes 16 malfunction events in which the device reportedly had a decrease in pressure.- 2 events had no patient involvement; no patient impact.- 13 events had patient involvement; no patient impact.- 1 event had insufficient information received.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h6, h10 16 previously reported events are included in this follow-up record.Product return status 12 devices were received.4 devices were not available for evaluation.

• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16807849
• Report Number: 3015967359-2023-00980
• Device Sequence Number: 20378716
• Product Code: KCY
• UDI-Device Identifier: 07613154589647
• UDI-Public: 07613154589647
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 16
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/24/2024

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
• Device Model Number: 5920011000
• Device Catalogue Number: 5920011000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 03/31/2023; 03/31/2023; 03/31/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 07/27/2023; 10/25/2023; 01/24/2024
• 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