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

Device Problems Unable to Obtain Readings (1516); Defective Component (2292)

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

Event Date 09/04/2019

Event Type  malfunction  

Event Description

After induction the anesthesia machine had a gas sensor fail.The etco2, o2 and desflurane were no longer reading any measurements.The anesthetic had to be converted to a iv anesthetic and a portable ventilator was utilized along with a bis monitor.The pt was stable throughout.

• Brand Name: PERSEUS
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; 3135 quarry rd.; telford PA 18969
• MDR Report Key: 9139918
• MDR Text Key: 160722834
• Report Number: 9139918
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/09/2019,09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA