MAUDE Adverse Event Report: WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H700150

Device Problem Communication or Transmission Problem (2896)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During the procedure, while the patient was on the table, the amplifier was unable to connect to the claris workmate system.Remote troubleshooting, pointed to a post failure.The procedure was cancelled due to this issue.There were no adverse patient consequences due to this issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported incident could not be determined.

Manufacturer Narrative

One claris¿ amplifier was received for evaluation.Evaluation testing was successful.Based on the investigation and information provided to abbott, the reported event was not confirmed, and the root cause remains undetermined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: WORKMATE¿ CLARIS¿ DISPLAY PLUS AMPLIFIER
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• MDR Report Key: 11177484
• MDR Text Key: 227029928
• Report Number: 2184149-2020-00244
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001504
• UDI-Public: 05415067001504
• Combination Product (y/n): N
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2021

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
• Device Operator: Health Professional
• Device Model Number: H700150
• Device Catalogue Number: H700150
• Device Lot Number: 5834101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/18/2021; 10/28/2021
• Supplement Dates FDA Received: 02/18/2021; 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other