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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

The affected device was examined by service technician and information was provided for further investigation.The investigation also considered information gained from comparable cases.Based on the reported error codes the root cause of the event was determined a deviation in the microprocessor-bus-configuration on the pcb control.Such a deviation within the electronic system will cause a software-controlled restart (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.If the deviation is corrected by this reset the device will continue ventilation with last settings after not later than 12 sec.Furthermore, an issue regarding the flow measurement was reported.A deviation regarding the flow measurement will be detected by the device and alarmed accordingly.The ventilation will be continued.The customer has to act according to the troubleshooting table in the instructions for use.The flow sensor is a wear and tear part and has to be replaced if faulty.An improved version of the cable harness spirologsensor is available in case a faulty cable harness spirologsensor has to be replaced.The device reacted as specified to a detected deviation within the electronic system and performed a restart in order to remedy the issue; this restart was accompanied by an alarm.Further alarms were generated in order to alert the user of the issue regarding the flow measurement.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 generated several device error codes ; the device failed with alarms.There were no patient consequences 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: 11483503
• MDR Text Key: 256540260
• Report Number: 9611500-2021-00106
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675016403
• UDI-Public: (01)04048675016403(11)190819(17)220107(93)8414450-48
• 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: 03/15/2021

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 Catalogue Number: 8414000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2019
• 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