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

Catalog Number 8417801

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Neurological Deficit/Dysfunction (1982)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

An analysis of the provided log files was performed.This included a review of the user log records which document user setting changes and a review of the alarm history for the requested days.Based on the log evaluation no indication for a malfunction of the savina 300 was found.It was noticed when reviewing the alarm records that the entry "minute volume low" was logged frequently over a long time starting (b)(6) 2019 at 7:26 pm until (b)(6) at 09:15 am.But no information was available providing a statement which alarm limits were set.

Event Description

It was reported that the patient connected to a savina 300 suffered cardiac arrest and hypoxia.Despite resuscitation was successful, the patient suffered severe neurological consequences.A device log analysis for (b)(6) and (b)(6) 2019 was requested by the hospital.

• 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
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 9178198
• MDR Text Key: 165971233
• Report Number: 9611500-2019-00321
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)170719(17)200501(93)8417800-31
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K180779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8417801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2017
• 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