MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. PERSEUS A500; GAS-MACHINE, ANESTHESIA

Model Number MK06000

Device Problems Display or Visual Feedback Problem (1184); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2023

Event Type  malfunction  

Event Description

"anesthesia machine at south campus or (operating room) had sample line occlusion alarm.Sample line was changed, and plastic gage was observed, and alarm continued." manufacturer response for anestehsia machine, (brand not provided) (per site reporter).Oem (original equipment manufacturer) replaced sample line pump with upgraded pump.

• Brand Name: PERSEUS A500
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 6 tech drive; andover MA 01810
• MDR Report Key: 17170810
• MDR Text Key: 317554392
• Report Number: 17170810
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MK06000
• 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: 06/09/2023
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1