MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY COMPANY GEM PREMIER 4000; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2017

Event Type  malfunction  

Event Description

This error was on an abg blood gas machine (gem 4000).The new cartridge installed showed a ground fault error and was expelled by the machine automatically.This was a 150 sample cartridge where no samples were used.Information on the cartridge in question is; reference # 00027415004, lot 721200025/181499280.This error has been called into instrumentation laboratory and we have received a case number.A new cartridge will be sent to the hospital.

• Brand Name: GEM PREMIER 4000
• Type of Device: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): INSTRUMENTATION LABORATORY COMPANY; 180 hartwell rd.; bedford MA 01730
• MDR Report Key: 6904298
• MDR Text Key: 87775323
• Report Number: 6904298
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2017
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1