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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2023
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: 31 events were reported for this quarter.Product return status: 16 devices were received.1 device was not available for evaluation.14 device investigation types have not yet been determined.Additional information: 31 devices were not labeled for single-use.31 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 31 malfunction events in which the device reportedly had a decrease in pressure.23 events had no patient involvement; no patient impact.7 events had patient involvement; no patient impact.1 event had insufficient information received.
Event or Problem Description
This report summarizes 31 malfunction events in which the device reportedly had a decrease in pressure.24 events had no patient involvement; no patient impact.6 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: 31 previously reported events are included in this follow-up record.Product return status: 25 devices were received.6 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: 17993144
• Report Number: 3015967359-2023-02377
• Device Sequence Number: 7469434
• 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: 31
• 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): 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 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: 09/30/2023
• Supplement Date Received by Manufacturer: 09/30/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 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