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

Catalog Number 8414000

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2023

Event Type  malfunction  

Event Description

It was reported that during use on a patient the device suddenly stopped ventilation and the patient was connected to back up / spare device.The user facility report to the national ca emphasised the potential of a lifethreatening situation but did not state or confirm an injury or serious impairment in state of health of the affected patient.The issue was only internally reported and handled by the hospital, there was no contact or involvement of draeger serive.No further information about the event and follow-up actions could be obtained.

Manufacturer Narrative

Due to the very little information the manufacturer is not able whether to confirm a potential device malfunction nor a clear cause of the reported "ventilation stop" - the manufacturer highlights that the ventilation is always monitored, a stop of ventilation will be detected and alarmed accordingly - even this aspect could not be confirmed or denied by the hospital, device logs are not available.Finally - no conclusion can be drawn.H3: device not available for investigation.

• Brand Name: SAVINA
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16859263
• MDR Text Key: 314447315
• Report Number: 9611500-2023-00162
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• PMA/PMN Number: K003068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8414000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1