MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA DRAGER SAVINA 300 VENT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number SAVINA 300

Device Problems Self-Activation or Keying (1557); Appropriate Term/Code Not Available (3191)

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

Event Date 12/18/2020

Event Type  malfunction  

Event Description

Changing the patient's hme filter to a larger one on his bipap.Upon changing it the red alarm popped up on the screen and said "high mv".Then the vent alarmed and flashed "critical error", and turned off for a few seconds then turned itself back on to the same settings and started ventilating again.The rep that came to fix it today said that the filter change had nothing to do with it was a coincidence.Fda safety report id #(b)(4).

• Brand Name: DRAGER SAVINA 300 VENT
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA
• MDR Report Key: 11071964
• MDR Text Key: 223809600
• Report Number: MW5098529
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675411628
• UDI-Public: 04048675411628
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2020

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
• Device Model Number: SAVINA 300
• Device Catalogue Number: 8417801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 74