MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE

Catalog Number 8416000

Device Problems Premature Discharge of Battery (1057); Low Battery (2584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The root cause of the observed behavior were batteries which aged prematurely after an update of the power supply software to 1.50 end of 2015.A voluntary recall is initiated: dräger has developed interim solutions with customers who carry out transports frequently to prevent the potential for ventilator failure during the typical clinical workflow.Information of users via fsn about this issue and provide specific advices to customers using devices for transport downgrade of the power supply software to fw 1.49 and replacement of batteries preventive replacement of batteries each 6 months until final solution is available.Notification of affected customers until february 8th, 2016 sw dowgrade from 1.50 to 1.49 and exchange of affected batteries of ps500 until july 31, 2016.The device alarmed prior to battery depletion, the stop of ventilation was announced via the secondary alarm source as specified.

Event Description

It was reported: "very short battery life, alarm "battery ow", after a few seconds the device switched off.There was no injury reported.

• Brand Name: INFINITY ACS WORKSTATION CC
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: frank clanzett ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 5412399
• MDR Text Key: 38228596
• Report Number: 9611500-2016-00032
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K093633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• 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: 8416000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• 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