MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACROBAT SUV STABILIZER SYSTEM; STABILIZER, HEART

Model Number	ACROBAT SUV STABILIZER SYSTEM
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id# (b)(4).The device has not yet been returned to (b)(6) for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
Related to (b)(4).(b)(6) reported the customer reports the receipt of acrobat suv vacuum stabilizer system, sent by the dhl courier of a damaged package with unsaleable goods.No patient involvement.
Additional Manufacturer Narrative
Trackwise id#: (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).Corrected sections: d10 (device available for eval?) corrected from "yes" to "no", d10 (return to manufacture date) corrected from 06/20/2022 to blank, h3(device evaluated by mfg?) corrected from "yes" to "other." updated sections: b4, e3, g4, g7, h2, h6, h10, h11.The device was not returned to the factory for evaluation, however a photograph was provided by the account.A photographic inspection was conducted.There was no signs of clinical use or evidence of blood observed.The outer shipping box was observed to be damaged and slightly opened on both ends.The shipping box was observed to have "repacked" tape on top of the normal shipping tape.The product boxes inside the shipping box were not observed.Based on the photographic inspection, the reported failure "packaging or shipping problem" was confirmed, however we are unable to determine when the damage occurred.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.Root cause determination: the root cause is undetermined, since it cannot be confirmed when the packaging damaged occurred.The lot # 3000137186 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.H3 other text : device not returned.

• Brand Name: ACROBAT SUV STABILIZER SYSTEM
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 12610883
• Report Number: 2242352-2021-00833
• Device Sequence Number: 1335195
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: 00607567900004
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2023

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 Expiration Date: 11/03/2022
• Device Model Number: ACROBAT SUV STABILIZER SYSTEM
• Device Catalogue Number: OM-9000Z
• Device Lot Number: 3000137186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 06/20/2022; 09/27/2023
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 07/18/2022; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown