MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY CHARGER; VENTRICULAR (ASSISST) BYPASS

Model Number	1600
Medical Device Problem Codes	Failure to Charge (1085); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the battery charger was intermittently charging batteries.It was noted that the power cable did not stay plugged into the base of the charger, it was very loose.The battery charger has been exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted based on a secondary review of the reported event of a battery charger intermittently charging batteries and the power cable not staying plugged into the base of the charger did not cause or contribute to death or serious injury and is not likely to do so if it were to recur.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A supplemental report is being submitted for analysis and investigation completion.Product event summary: the battery charger (bch102608) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the p erformance of the device in relation to the reported event.Failure analysis of the returned device revealed that the battery charger passed visual inspection and functional testing.No anomalies were observed on the input connector.The battery charger was able to charge the test batteries on the charging bays.The battery charger properly connected to the test battery charger ac adapter; all connections were stable with no abnormalities observed.Additionally, internal inspection did not reveal any anomalies.As a result, the reported events could not be confirmed.A possible root cause of the reported event can be attributed, but not limited to a marginal connection between the battery charger and battery charger ac adapter.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY CHARGER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 12324822
• Report Number: 3007042319-2021-05672
• Device Sequence Number: 4425079
• Product Code: DSQ
• UDI-Device Identifier: 00888707000130
• UDI-Public: 00888707000130
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2021

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: 1600
• Device Catalogue Number: 1600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 10/07/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 08/27/2021; 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD; 1103 VAD
• Patient Age: 60 YR