MAUDE Adverse Event Report: HEARTMATE MOBILE POWER UNIT AC POWER CORD; VENTRICULAR (ASSISST) BYPASS

Model Number	107760
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involved.
Event or Problem Description
It was reported that the power cord for the mobile power unit (mpu) did not have any labeling.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the heartmate mobile power unit ac power cord not having any labeling was not confirmed.The power cord was returned to abbot burlington, ma for analysis.The heartmate mobile power unit ac power cord was visually inspected along with a test power cord and there seemed to be no visual differences other than the part number on the test power cord.The reported event of a lack of labeling was not able to be confirmed as it seemed to have all the necessary labeling.Multiple attempts have been made to obtain additional information about the reported event such as what the mobile power unit (mpu) power cord was missing for labeling; however, no response was given.The root cause for the reported event could not be conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE MOBILE POWER UNIT AC POWER CORD
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• MDR Report Key: 11913717
• Report Number: 2916596-2021-02824
• Device Sequence Number: 19883643
• Product Code: DSQ
• UDI-Device Identifier: 00813024011484
• UDI-Public: 00813024011484
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 107760
• Device Catalogue Number: 107760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1