MAUDE Adverse Event Report: TERRAGENE S.A. STRYKER SLCD12; AUTOREADER INCUBATOR

Model Number STRYKER SLCD12

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

There were no reported medical interventions, surgical delays, or any adverse consequences for patient and/or user with this event.No evidence of the device malfunction available.However, the if there was a malfunction, it caused the device to fail to perform its essential function and compromise the device's monitoring effectiveness, since it would not be able to process biological indicators.If this were to recur, the lack of biological indicators processing could affect the load release, which could contribute to a serious injury if it were to recur due to lack of sterile material.

Event Description

It was reported by the customer that the incubator has some ports not working properly.The device was sent back to the distributor but no further information was provided.

• Brand Name: STRYKER SLCD12
• Type of Device: AUTOREADER INCUBATOR
• Manufacturer (Section D): TERRAGENE S.A.; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer (Section G): TERRAGENE S.A.; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• Manufacturer Contact: hernando carrizo ; ruta nac. no. 9, km 280; parque industrial micropi; alvear, santa fe 2130 ; AR 2130
• MDR Report Key: 18475644
• MDR Text Key: 332900671
• Report Number: 3013145340-2024-00019
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 07798164678175
• UDI-Public: 07798164678175
• Combination Product (y/n): N
• PMA/PMN Number: K191021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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 Operator: Health Professional
• Device Model Number: STRYKER SLCD12
• Device Lot Number: SLCD120821
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1