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

Catalog Number 8417801

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 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

The event dates back to (b)(6) 2020, already.The device was examined by a dräger service technician soon after the event but the hospital did not disclose that time that the shut-down occurred during use on a patient.The technician could verify that operation on battery did not work properly, and traced it back to an outdated battery.The battery was replaced, the device was tested, and is back in use since then without further problems reported to date.The savina is equipped with an internal battery that is intended to cover mains power losses or ensure ongoing ventilation during a patient transport.It is clearly stated in the ifu the internal battery must be checked in regular intervals and must be replaced after 2 years.The particular device involved in the event is 2.5 years old and was still equipped with the initial battery.One effect of battery ageing typically is that the characteristic discharging curve changes over time, which results in an imprecise runtime forecast.Dräger finally concludes that lack of maintenance was at least a contributing factor in the event.

Event Description

It was reported that the device suddenly alarmed for battery depletion and shut down during patient transport despite a 100% charging status was displayed during pre-use check.The device was replaced; no patient consequences have occurred.

• 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
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11025250
• MDR Text Key: 222417739
• Report Number: 9611500-2020-00462
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675251422
• UDI-Public: (01)04048675251422(11)180305(17)210101(93)8417800-35
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8417801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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