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

Model Number	Z-800
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pump was received on 10/6/2021 and tested on 10/11/2021.Pump was tested with the following protocol: speaker test: 1.Go to the infusion screen and press config to enter the configuration menu.2.Select factory set and highlight alarm volume.3.Press numeric 1 key up or down to change the volume from low to mid to high.Check if the sound is as expected.4.If sound is low at low volume, mid at mid volume, and high at high volume, pump passes test.If not, pump fails test.Result: pump passed test.Pump's alarm was working during testing, including when an infusion was complete.Reported issue not confirmed.Test completed 10-11-2021.Pump was tested and meets full specification.The pump was scrapped on 5/17/2023.
Event or Problem Description
On 10/7/2021 zyno solutions received an stating that pump (b)(6) does not alarm when an infusion is complete.Operator biomed tech.Medication n/a.No patient involved, patient not harmed.(b)(6) 2021.

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP
• Common Device Name: LARGE VOLUME INFUSION PUMP
• Manufacturer (Section D): ZYNO MEDICAL; 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: 18838890
• Report Number: 3006575795-2024-00036
• Device Sequence Number: 12574243
• Product Code: FRN
• UDI-Device Identifier: 00814371020006
• UDI-Public: 00814371020006
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Consumer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

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: Lay User/Patient
• Device Model Number: Z-800
• Device Lot Number: 20110308-SH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown