MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. Medline; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number HCS4607MN

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Date 08/07/2022

Event Type  malfunction  

Event Description

Etco2 tubing not reading on patient's pca.Changed the module 3x, changed the brain 1x, changed the tubing 3x, ultimately didn't read, so patient was unable to utilize pca.This was a new/substitute product.

• Brand Name: Medline
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15601916
• MDR Text Key: 301736990
• Report Number: 15601916
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HCS4607MN
• Device Catalogue Number: HCS4607MN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Male
• Patient Weight: 108 KG