MAUDE Adverse Event Report: GE HEALTHCARE, LLC DATEX-OHMEDA; GAS-MACHINE, ANESTHESIA

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Event Description

After the patient was intubated the mechanical ventilator stopped working.The device information refers to the ge datex-ohmeda aisys anesthesia system ((b)(4)).

• Brand Name: DATEX-OHMEDA
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE, LLC; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 12391235
• MDR Text Key: 268909711
• Report Number: 12391235
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/23/2021

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 Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Date Report to Manufacturer: 08/31/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA