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

Catalog Number 8414000

Device Problems Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

It was reported that the device suddenly posted a power fail alarm during use and shut down.The patient was immediately connected to another device; no patient consequences have reportedly occurred.

Manufacturer Narrative

The event dates back to (b)(6) 2021 and, the user facility did not involve the local dräger s&s organization in examination and repair of the device that time.The device is not under a service contract; the hospital performs preventive maintenance and repairs on own behalf and responsibility.Upon recept of the user facility report, dräger was contacting the hospital to obtain further information.It was reported that the device was inspected by a hospital technician who found a lot of dust inside the unit and thus, came to the conclusion that overheating of electronic parts has led to short circuit in the power supply.This resulted in the unexpected shutdown then.Dräger finally concludes that the likely root cause for the reported event was lack of preventive maintenance.The device has responded as designed upon the power supply malfunction and alerted the user by means of a corresponding acoustical alarm which is buffered by an independent power source.No patient consequences have occurred.

• 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
• MDR Report Key: 14560516
• MDR Text Key: 297362380
• Report Number: 9611500-2022-00128
• Device Sequence Number: 1
• Product Code: CBQ
• 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: 06/01/2022

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 Catalogue Number: 8414000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1