MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA 4; VENTILATORS, INTENSIVE CARE

Catalog Number 8411740

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Failure to Deliver (2338); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but is not yet concluded; the results will be provided in a follow-up report.

Event Description

It was reported that "during use on patient, the nurse found the breathing circuit was disconnected but the device didn't occur any alarms.The patient can't get the ventilation from the device as intended that could cause the risk of apnea.Then she connected the circutis with the patient again, continue to use mannual ventilator on the patient." there were no patient consequences reported.

Event Description

It was reported that "during use on patient, the nurse found the breathing circuit was disconnected but the device didn't occur any alarms.The patient can't get the ventilation from the device as intended that could cause the risk of apnea.Then she connected the circuits with the patient again, continue to use manual ventilator on the patient." there were no patient consequences reported.

Manufacturer Narrative

As only information available the provided logfile was analysed for the investigation.As the device has been in use after the event, the log entries concerning given alarms and device settings from the date of event have been overwritten by newer entries.The statistical error log contains entries starting in 2014 and there is no indication of a technical failure.A technical failure regarding the alarm system would result in an entry in the statistical error log.In case the breathing hose is disconnected, the ventilator will detect this and generate optical and acoustical alarms according to the set parameters within the given thresholds.Based on the current parameters and alarm limits set by the user, the time until a disconnection is alarmed may deviate.As no device failure was found, it is likely that the criteria for a disconnection alarm were not yet met in the reported ventilation situation.It was concluded that the ventilator reacted according to specification in the given situation.The ifu states that the alarm limits have to be set in accordance to patient's need.Otherwise a delayed alarm is possible.

• Brand Name: EVITA 4
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10319252
• MDR Text Key: 200291837
• Report Number: 9611500-2020-00261
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K980642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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: 8411740
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1