MAUDE Adverse Event Report: ZYNO MEDICAL, LLC Z-800F; PUMP, INFUSION

Model Number	Z-800F IV INFUSION PUMP
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During routine service at right way medical, the device was observed to have no audible alarms.The speaker was nonfunctional, resulting in the absence of sound when keys were pressed, as well as no audible indication when the infusion was complete.A review of the device¿s serial number history revealed no prior similar complaints.The failure mode was confirmed, and the probable cause was determined to be a component-related issue.The problem was successfully resolved by replacing the speaker assembly.(b)(4).
Event or Problem Description
During routine service at right way medical, the device was observed to have no audible alarms.The speaker was nonfunctional, resulting in the absence of sound when keys were pressed, as well as no audible indication when the infusion was complete.No patient involvement was reported.

• Brand Name: Z-800F
• Common Device Name: PUMP, INFUSION
• 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: fred lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 22984744
• Report Number: 3006575795-2025-00432
• Device Sequence Number: 21174837
• Product Code: FRN
• UDI-Device Identifier: 00814371020013
• UDI-Public: 00814371020013
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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: Z-800F IV INFUSION PUMP
• Device Catalogue Number: Z-800F IV INFUSION PUMP
• Device Lot Number: 615260
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 01/19/2017
• 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