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

Catalog Number 8414000

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation was based on the description of event and the log file which was provided for the affected device.Based on the log file analysis, a device restart could be confirmed and a sporadic and reversible deviation within the electronic of the pcb control was identified to be the root cause.A deviation within the electronic system will cause a software-controlled reset of the whole electronic system.The pneumatic system opens which reduces airway pressure to ambient pressure and spontaneous breathing is possible for the patient.This system-reset is combined with an audible and visible alarm of high priority in order to alert the user of the device restart.A sporadic, reversible deviation is corrected by this reset and the device continues ventilation with last settings after not later than 12 seconds.The device reacted as specified and alarmed accordingly to the detected deviation.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 black screen and turn to be normal immediately, alarmed with "device failure".There was 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: 10447155
• MDR Text Key: 204357000
• Report Number: 9611500-2020-00302
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)180926(93)8414000-37
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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?: Yes
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2018
• 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