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

Catalog Number 8414900

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

For the investigation the provided information and the logfile were analyzed.On july 28th, 2020 between 07:43 pm and 7:50 pm the device was powered by internal battery.Without external batteries evita switches over from mains to dc operation on internal batteries without interrupting the ventilation.By doing this the device alarms audible and visible with ¿int.Battery activated¿.In case the batteries are getting depleted, the device alarms audible and visible with "int.Battery only 2 minutes left !!" (mid priority).After additional 2 minutes the evita alarm audible and visible with ¿int.Battery discharged !!!¿ (high priority).If the internal batteries are depleted the device shuts down with audible power failure alarm.The power failure alarm lasts for at least 2 minutes until the internal gold caps capacitors are depleted.In this case of power failure the emergency-breathing valve is open allowing spontaneous breathing of the patient.According to the specification the device posted the alarm «int.Battery activated !!! ».However the alarms "int.Battery only 2 minutes left !!" and ¿int.Battery discharged !!!¿ (high priority) were not posted due to the limited capacity of the internal battery.At 7:50 pm the device switched off with power failure alarm as specified.The ifu instructs to check the battery regularly and to replace it after two years at the latest.It was found by the service engineer on site that the batteries were out of date.No technical failures were found during logfile analysis.The internal and external batteries were replaced and the unit was tested and released for use without further issue.

Event Description

It was reported during use that the ventilator had powered off without warning.There was no patient injury reported.

• Brand Name: EVITA XL
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 10486876
• MDR Text Key: 208374213
• Report Number: 9611500-2020-00311
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8414900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2006
• 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