MAUDE Adverse Event Report: KDL MEDICAL DBA CHASE MEDICAL TRIPOD STABILIZER-NYLON FASTRACT; STABILIZER, HEART, PRODUCT CODE: MWS

Model Number	STB-30C4S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot history file was reviewed for d808013.The work order was for a lot of 30 stabilizers.All required paperwork was present and complete documenting that the stabilizers were manufactured and inspected per procedure.All units passed the required inspections.Stabilizers undergo a 100% packaging inspection which includes 8 different inspection points related to the feet on each unit.During the inspection, it is verified that the o-rings are present as the o-rings are used to secure the feet to the device.There is also a 100% post-sterile inspection and a 100% visual pre-shipment inspection in place to look for this defect.All 3 inspections took place and are recorded.The probable cause of this defect based upon 2 prior investigations, is that the o-ring sustained a minor stress during the assembly process which was not visible during the inspections.The o-ring likely broke in transit allowing one foot to become dislodged.The foot and o-ring likely remained in the tray and were discarded when the stabilizer was removed.The incident rate of this failure type, specifically after the device has been through the 100% inspections if very low but possible.This potential failure mode is already identified in the fmea and is known to the assemblers.This is the 11th complaint of a split o-ring since the 2008 investigation and the 3rd since the 2016 investigation.We will continue to monitor for further occurrence.
Event or Problem Description
As reported - stabilizer was missing one foot and o-ring.This was noticed prior to use and another stabilizer was used without harm to the patient.Chase medical was notified of the complaint on 10/23/2019 by the sales representative with mba medical.The event occurred at (b)(6).

• Brand Name: TRIPOD STABILIZER-NYLON FASTRACT
• Common Device Name: STABILIZER, HEART, PRODUCT CODE: MWS
• Manufacturer (Section D): KDL MEDICAL DBA CHASE MEDICAL; 885 e. collins blvd.,; suite 110; richardson TX 75081
• MDR Report Key: 9324815
• Report Number: 1649139-2019-00001
• Device Sequence Number: 2936970
• Product Code: MWS
• UDI-Device Identifier: 00899054002449
• UDI-Public: 00899054002449
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: C024062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 09/18/2021
• Device Model Number: STB-30C4S
• Device Catalogue Number: STB-30C4S
• Device Lot Number: D808013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1