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	06/30/2023
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 46 events were reported for this quarter.Product return status 35 devices were received.11 device investigation types have not yet been determined.Additional information 46 devices were not labeled for single-use.46 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 46 malfunction events in which the device reportedly had a decrease in pressure.- 36 events had no patient involvement; no patient impact.- 8 events had patient involvement; no patient impact.- 2 events 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 46 events were previously reported during the reporting period; however, 1 previously reported event in this report should have been included under mfr report # 3015967359-2023-01525.- 45 previously reported events are included in this follow-up record.
Event or Problem Description
This report summarizes 45 malfunction events in which the device reportedly had a decrease in pressure.35 events had no patient involvement; no patient impact.8 events had patient involvement; no patient impact.2 events 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: 45 events were previously reported during the reporting period; however, 1 previously reported event in this report should have been included under mfr report # 3015967359-2023-01525.44 previously reported events are included in this follow-up record.Product return status: 40 devices were received.2 devices were not available for evaluation.2 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 44 malfunction events in which the device reportedly had a decrease in pressure.35 events had no patient involvement; no patient impact.8 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: b5, h6, h10 44 previously reported events are included in this follow-up record.Product return status 41 devices were received.3 devices were not available for evaluation.
Event or Problem Description
This report summarizes 44 malfunction events in which the device reportedly had a decrease in pressure.- 34 events had no patient involvement; no patient impact.- 9 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: (b)(4) previously reported events are included in this follow-up record.Product return status (b)(4) devices were received.(b)(4) devices were not available for evaluation.
Event or Problem Description
This report summarizes (b)(4) malfunction events in which the device reportedly had a decrease in pressure.- (b)(4) events had no patient involvement; no patient impact.- (b)(4) events had patient involvement; no patient impact.- (b)(4) event had insufficient information received.

• 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: 17401587
• Report Number: 3015967359-2023-01676
• Device Sequence Number: 8942145
• 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: 44
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/29/2024

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: 07/17/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 07/17/2023; 07/17/2023; 07/17/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 07/27/2023; 10/25/2023; 01/24/2024; 04/29/2024
• 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