MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; GAS-MACHINE, ANESTHESIA

Model Number PERSEUS A500

Device Problems Gas Output Problem (1266); Noise, Audible (3273)

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

Event Date 10/04/2019

Event Type  malfunction  

Event Description

Gas bench failure on anesthesia machine during patient use.Used backup system.Manufacturer response for anesthesia, delivery unit, with monitor, north american drager (per site reporter).Work performed: completed repair on the perseus unit.I was able duplicate reported problem of gas measurement failure.Downloaded and reviewed service logs and found several entries pertaining to noise on the sensor head.Replaced ilca3 sensor.Verified vaporizer outputs.

• Brand Name: PERSEUS A500
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; 3135 quarry rd; telford PA 18969
• MDR Report Key: 9488727
• MDR Text Key: 171823448
• Report Number: 9488727
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PERSEUS A500
• 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: 10/11/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1