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

Model Number STRYKER SLCD12

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Distributor didn't provide enough information to properly understand the nature of the complaint.No device-related death or serious injury was reported.However, if it were to recur, the calibration malfunction could possibly affect the essential function of the device causing the device to fail to perform its essential function and compromise the sterilization process monitoring effectiveness which could, ultimately, contribute to a serious injury.

Event Description

A customer indicated that the incubator was not calibrating correctly because the hub was not working.

• Brand Name: STRIKER SLCD12
• Type of Device: 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: 18398363
• MDR Text Key: 332490681
• Report Number: 3013145340-2023-00006
• Device Sequence Number: 1
• Product Code: FRC
• UDI-Device Identifier: 07798164678175
• UDI-Public: 07798164678175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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 Model Number: STRYKER SLCD12
• Device Lot Number: SLCD121121
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1