MAUDE Adverse Event Report: TERRAGENE S.A WTL198-0079; AUTO-READER INCUBATOR

Model Number	WTL198-0079
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were no reported medical interventions, surgical delays, or any adverse consequences for patient and/or user with this event.Investigation suggested that the power supply was damaged.This malfunction could cause the device to fail to perform its essential function and compromise the sterilization process monitoring effectiveness by not being available for sterilization monitoring with the rapid bis, delaying the release of the sterilization loads, which could contribute to death or serious injury if it were to recur.
Event or Problem Description
It was reported that the incubator lights were turning on and of and it was beeping.It could not be use for incubation.

• Brand Name: WTL198-0079
• Common Device Name: AUTO-READER INCUBATOR
• Manufacturer (Section D): TERRAGENE S.A; ruta nacional no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A; ruta nacional no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nacional no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 18477795
• Report Number: 3013145340-2024-00022
• Device Sequence Number: 6784885
• Product Code: JOJ
• UDI-Device Identifier: 07798164677468
• UDI-Public: 07798164677468
• Combination Product (Y/N): N
• PMA/510(K) Number: K163646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2024

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
• Device Expiration Date: 10/01/2025
• Device Model Number: WTL198-0079
• Device Lot Number: WTL19800794020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown