MAUDE Adverse Event Report: MARPAC, INC MARPAC; ET TUBE HOLDER

Model Number	340
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	12/30/2021
Type of Reportable Event	Death
Event or Problem Description
Untrained staff used the et tube holder.The result was that the et tube slipped.It is unclear whether the et tube slipping was a factor contributing to the patient's death or not.This happened in the uk.

• Brand Name: MARPAC
• Common Device Name: ET TUBE HOLDER
• Manufacturer (Section D): MARPAC, INC; 4801 lincoln rd ne; albuquerque NM 87109
• Manufacturer (Section G): MARPAC, INC; 4801 lincoln rd ne; albuquerque NM 87109
• Manufacturer Contact: jeffrey alcalde ; 4801 lincoln rd ne; albuquerque, NM 87109 ; 5057645662
• MDR Report Key: 14655551
• Report Number: 1722095-2022-00001
• Device Sequence Number: 4904495
• Product Code: CBH
• UDI-Device Identifier: 00653658003406
• UDI-Public: (01)00653658003406
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2022

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 Expiration Date: 01/31/2024
• Device Model Number: 340
• Device Catalogue Number: 340
• Device Lot Number: 210217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White