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

Catalog Number	5920011000
Medical Device Problem Code	Increase in Pressure (1491)
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
Event or Problem Description
This report summarizes 2 malfunction events in which the device reportedly had an increase in pressure.1 event 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.Reported events 2 events were reported for this quarter.Product return status 2 device investigation types have not yet been determined.Additional information 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device reportedly had an increase in pressure.1 event had no patient involvement; no patient impact.Event 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 2 events were previously reported during the reporting quarter; however, 1 previously reported event was included under mfr report # 3015967359-2023-01676 but should be included under this report.3 previously reported events are included in this follow-up record.
Event or Problem Description
This report summarizes 4 malfunction events in which the device reportedly had an increase in pressure.- 4 events had no 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.Supplemental rationale corrected data: b5, h6, h10/ 3 events were previously reported during the reporting quarter; however, 1 previously reported event was included under mfr report # 3015967359-2023-01676 but should be included under this report.4 previously reported events are included in this follow-up record.Product return status 4 devices were 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: 17397014
• Report Number: 3015967359-2023-01525
• Device Sequence Number: 20721895
• 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: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2023

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
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 07/27/2023; 10/25/2023
• 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