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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Respiratory Distress (2045)

Event Date 01/16/2019

Event Type  malfunction  

Event Description

Doctor attempted to swap out the absorbent canister during a case.After the swap, the patient's inspired co2 levels increased.Dr was not able to resolve the problem.Ended up having to bag patient using an ambu-bag and transport patient to another operating room down the hall.Manufacturer response for anesthesia ventilator, (brand not provided) (per site reporter).They came out, tested the ventilator and stated the problem was that the absorber was installed incorrectly.The ventilator passed all "tested" and was deemed ready to be returned to service.

• Brand Name: PERSEUS A500
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; 3135 quarry rd.; telford PA 18969
• MDR Report Key: 8276856
• MDR Text Key: 134067249
• Report Number: 8276856
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/22/2019
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1