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

Model Number	Z-800W
Medical Device Problem Codes	Device Alarm System (1012); No Audible Alarm (1019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was confirmed.The pump was tested on 07/19/2019 and failed the volume test.The speaker assembly was replaced and the pump was retested to meet full specification.An email was sent to zyno medical on 07/19/2019 by the distributor but the distributor did not follow the established protocol to fill out the complaint form until 09/12/2019.Zyno medical determined this is a mdr reportable event on 09/13/2019.
Event or Problem Description
On 07/19/2019, a distributor of zyno medical reported a speaker malfunction issue.A user facility representative emailed the distributor on 07/01/2019, stating that a pump had a speaker that "went out, no sound." no patient was involved.The medication associated with the incident was gazvya.Device operator was a rn.

• 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
• MDR Report Key: 9056940
• Report Number: 3006575795-2019-00027
• Device Sequence Number: 3069895
• Product Code: FRN
• UDI-Device Identifier: 00814371020020
• UDI-Public: 00814371020020
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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: Health Professional
• Device Model Number: Z-800W
• Device Catalogue Number: Z-800W
• Device Lot Number: 20120222-SH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 09/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1