MAUDE Adverse Event Report: ST. JUDE MEDICAL WI-BOX; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number	C12783
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an rfr physiology study, when trying to acquire ao pressure, the wi-box ao transmitter was unable to establish connection with the pressurewire x.The red light came on (not ready indicator) on the wi-box and powered off.All the connections to the wi-box were checked, but the issue persisted.The procedure was aborted due to this issue.The wi-box was replaced and the issue was resolved.There were no adverse patient consequences due to this issue.
Additional Manufacturer Narrative
One wi-box p was received into the lab for analysis.A functional test was performed utilizing a known good quantien unit & pressure wire upon which the returned wi-box was unable to zero pa.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, root cause of the field reported event citing unable to zero pa was successfully isolated to a hardware failure on a system level component.

• Brand Name: WI-BOX
• Common Device Name: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11410952
• Report Number: 2184149-2021-00048
• Device Sequence Number: 3816065
• Product Code: DRG
• UDI-Device Identifier: 05414734054140
• UDI-Public: 05414734054140
• Combination Product (Y/N): N
• PMA/510(K) Number: K111854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: Health Professional
• Device Model Number: C12783
• Device Catalogue Number: C12783
• Device Lot Number: 6391659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1