MAUDE Adverse Event Report: TERRAGENE S.A STRYKER 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 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

As reported by the technical personnel, the root cause, in this case, can be linked to the temperature sensor being disconnected.No device-related death or serious injury was reported.However, if it were to recur, risk of overheating due to a disconected component inside the device could affect the device in a catastrophic manner that may lead to a serious injury.

Event Description

A customer informed that a new device showed an intense smoke smell.No further information was provided as if it was out of the box or as a result of the firs use.

• Brand Name: STRYKER 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: 18392758
• MDR Text Key: 331336655
• Report Number: 3013145340-2023-00003
• Device Sequence Number: 1
• Product Code: FRC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2023

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 Expiration Date: 12/31/2022
• Device Model Number: STRYKER SLCD12
• Device Lot Number: SLCD124820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1