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

Catalog Number 8417801

Device Problems Premature Discharge of Battery (1057); Loss of Power (1475); Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but is not closed yet.The final results will be transmitted within a follow-up report.

Event Description

It was reported while a patient was being transported with the ventilator and after 4 minutes the ventilator shut down.The battery did not last the length of time it should.It is either not charging or holding a charge.Bagged the patient until they could plug the unit into ac.No reported patient injury.

Manufacturer Narrative

The affected savina 300 was produced in june 2017.The description of event indicates that the savina 300 is used in the hospital for patient transport.The ifu recommends to use additional external batteries for internal hospital transport.It was found that only the internal battery was used.Analysis of the log file confirms that the device shut down due to a depleted or worn-out battery.The logfile further shows that the lifetime of the internal battery has expired.The ifu cautions the user to make sure that the batteries are adequately charged both before and after patient transport.It also states: "the charging time increases significantly when the battery is warm, e.G., from high ambient temperatures or after a deep discharge.The maximum operating time is achieved when the battery is new and fully charged.The operating time depends on the following factors: ¿ state of charge ¿ age ¿ number of charging cycles ¿ speed of the blower (for increased loads, e.G., through increases in ventilation pressure or flow acceleration, the operating time is reduced).If savina 300 is powered by the internal battery, the charge state is indicated in the header bar of the screen during operation." if the savina 300 - operated with a functional internal battery - is not connected to mains power or equipped with an external battery, the unit switches to the internal battery with audible alarm and the display message "internal battery activated" occurs.With internal battery operation, the charging status of the internal battery is displayed continuously.Upon further decrease in capacity <30% the device alerts with a medium priority alarm.Before the end of the operating time (<10% remaining capacity) the device alarms with a high priority alarm and ensures a remaining operating time of 5 minutes.When fully discharged, the ventilation stops and the device switches off with a power failure alarm (buzzer) with high priority, which remains active for at least 2 minutes.New batteries were installed and the unit was tested passing all tests.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

Please refer to the initial-report.

• 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
• MDR Report Key: 8513597
• MDR Text Key: 145121447
• Report Number: 9611500-2019-00122
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)170713(17)190601(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,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1