MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP

Model Number	Z800F
Medical Device Problem Codes	Device Alarm System (1012); Device Sensing Problem (2917); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device return requested.There are no previous complaints on this device related to the issue.The complaint will be reopened and updated in the event the device involved or additional information becomes available.A follow-up mdr will be submitted in the event additional information becomes available.A capa has been opened in order to fully investigate and address the root cause of the reported event.Reference to complaint # (b)(4).
Event or Problem Description
On 10/11/2024, znyo medical received a report from the customer stating the device was displaying a pressure error even after trying multiple new pressure sensors happened during testing.No report patient involved.
Additional Manufacturer Narrative
This supplement serves as a correction.The reported failure mode has been assessed as not reportable.Our evaluation determined that the event did not pose a risk to the health of patients, users, or bystanders.Additionally, the report did not allege a serious injury or death, nor would the recurrence of the reported issue be expected to cause or contribute to a serious injury or death.Reference to complaint #(b)(4).

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
• Common Device Name: LARGE VOLUME INFUSION PUMP
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 20546984
• Report Number: 3006575795-2024-01022
• Device Sequence Number: 20698000
• Product Code: FRN
• UDI-Device Identifier: 00814371020013
• UDI-Public: 00814371020013
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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
• Operator of Device: Other
• Device Model Number: Z800F
• Device Catalogue Number: Z800F
• Device Lot Number: 20160111-SH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose