There was no patient involved in this event.The pma number provided is associated with most recent approval.Manufacturer's investigation conclusion: the reported event of a broken shell/case was confirmed upon arrival of the returned power module (serial number: (b)(6)).Visual inspection of the unit revealed that the top housing, bottom housing, handle overlay, and one rubber foot were cracked broken.The damaged components were replaced.It was also noted that the battery clip was damaged.Preventative maintenance was performed, and the serviced power module then passed a full functional checkout and was found to perform as intended.The root cause of the observed damages cannot be conclusively determined through this investigation.Review of the device history record for the power module, serial number: (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate power module instructions for use (ifu) (rev.B) instructs users to regularly inspect the power module, and to not use a power module that appears damaged.The heartmate power module ifu (section 11.0 ¿routine maintenance¿) instructs users to bring their power module to an authorized service technician at least once per year for a thorough inspection and cleaning.The heartmate 3 patient handbook (rev.D) cautions the user to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
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