MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA 300; VENTILATORS, INTENSIVE CARE

Model Number 8417800

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019)

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

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided within a follow-up report.

Event Description

It was reported that the device has performed a restart (reset).No patient consequences have been reported.

Manufacturer Narrative

The log of the affected savina 300 was available for the investigation.Based on the logbook entries, it was confirmed that the device performed a warmstart on (b)(6) 2021 at 10:02 a.M.During ventilation.After the warmstart, active ventilation was resumed automatically.A temporary deviation in the software was identified as the cause of the problem, which was eliminated by the warm start.The device reacted as specified to the detected deviation by performing a restart.During the restart the ventilation is stopped, an audible and visible alarm of high priority is generated, and the pneumatic system opens to allow for spontaneous breathing.A restart last at most 12 seconds after which the ventilation is continued with the last settings.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the device has performed a restart (reset).No patient consequences have been reported.

• Brand Name: SAVINA 300
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11626521
• MDR Text Key: 245995352
• Report Number: 9611500-2021-00144
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)170804(17)200601(93)8417800-31
• Combination Product (y/n): N
• PMA/PMN Number: K180779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8417800
• Device Catalogue Number: 8417801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1