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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/07/2022

Event Type  malfunction  

Event Description

A capnography was reading artificially low on this machine during an or procedure for patient.

• Brand Name: APOLLO
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; 6 tech drive; andover MA 01810
• MDR Report Key: 15484977
• MDR Text Key: 300574852
• Report Number: 15484977
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2022

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA
• Patient Sex: Male
• Patient Weight: 75 KG