MAUDE Adverse Event Report: NULL; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Lot Number 4131851

Device Problem Component Missing (2306)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Event Description

It was reported that 1 pc of 71840a1 was missing in the unlabeled package.

Manufacturer Narrative

Corrected data: product code and common device name were added.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2021-08321.The report was submitted in error., corrected data: corrected information provided in h10.

• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section G): NULL
• MDR Report Key: 12309445
• MDR Text Key: 268091379
• Report Number: 3012307300-2021-08321
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4131851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1