MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA DRAEGAR; GAS-MACHINE, ANESTHESIA

Model Number APOLLO

Device Problem Protective Measures Problem (3015)

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

Event Date 01/13/2023

Event Type  Injury  

Event Description

"ventilator malfunction" alarmed during procedure while pt was connected to ventilator.Pt required manual ventilation for remainder of procedure.No adverse pt outcomes to report.

• Brand Name: DRAEGAR
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA
• MDR Report Key: 16278197
• MDR Text Key: 308644938
• Report Number: MW5114601
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: APOLLO
• Device Catalogue Number: 8606500-32
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Hispanic