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

Model Number 8417800

Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

The affected device was repaired by a third party and the log file was available for the investigation.It was reported by the customer that the device was repaired by replacing the internal battery.Based on the log entries it could be confirmed that on 26th july 2021 the device alarmed ¿internal battery failure¿ at 2:45, 4:48, 7:49, 10:31 and 11:28.This indicates the internal battery was faulty, worn-out, discharged or not installed.The log file contains no indication of a faulty alarm.The replacement of the internal battery was the correct measure.In case the device is operated on battery power and the internal battery is faulty, the device may shut down.This shutdown is accompanied by an acoustical power supply failure alarm that lasts at least two minutes and the emergency breathing valve is opened to allow for spontaneous breathing.The internal battery is a maintenance component, that needs to be checked every 12 months by service personnel and replaced if necessary.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 at around 10 am the device displayed a black screen and shut down without alarms after 5 minutes of usage.The patient was manually ventilated for 10 minutes, and the ventilator was replaced.No patient injury was reported.

• Brand Name: SAVINA 300
• 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: 12329983
• MDR Text Key: 268240046
• Report Number: 9611500-2021-00347
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)170908(17)200701(93)8417800-31
• Combination Product (y/n): N
• PMA/PMN Number: K180779
• 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: 08/17/2021

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 Model Number: 8417800
• Device Catalogue Number: 8417800
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2017
• 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