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 Urinary Retention (2119)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The provided information was used for the analysis.It was described that the device suddenly shut down and restarted twice.A software controlled restart of the whole electronic system is executed in case the device detects a deviation within the electronic system.The pneumatic system opens which reduces airway pressure to ambient pressure and spontaneous breathing is possible for the patient.This system restart is combined with an audible and visible alarm of high priority.If the failure is removed by this restart the device continues ventilation with the last settings.The device was repaired by a third party by replacing the power supply.No further issues were reported.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 during use on patient the device suddenly occurred shut down and restarted, and the restart reoccurred after running several minutes.The hospital checked the main power was stable, the problem could be on the power supply unit.No patient injury reported.

• Brand Name: SAVINA
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10526910
• MDR Text Key: 206727442
• Report Number: 9611500-2020-00323
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K003068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2011
• 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