MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE; VENTILATORS, INTENSIVE CARE

Catalog Number 8416400

Device Problems Delayed Alarm (1011); Premature Discharge of Battery (1057); Loss of Power (1475)

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

Event Date 11/05/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but is not yet concluded.The investigation result will be reported in a follow up-report.

Event Description

The customer reported that the ps500 battery showed a full charge on the cockpit screen before disconnecting ac power from the ventilator.After disconnecting ac power to the ventilator and while transporting a patient, the message "battery low" was posted after 10 minutes.Approximately 15 minutes after disconnecting ac power from the ventilator (5 minutes after "battery low" alarm), the ventilator shut down completely and a loud continuous audible alarm was heard.The customer then plugged ventilator ac power cord back into ac power and the ventilator powered back on and was again operational.No patient injury was reported.

Manufacturer Narrative

The provided log files were analyzed.The user's observation of an unexpected battery capacity loss could be confirmed.Investigation revealed that a non-specified unexpected reduction of battery capacity occurred when using the ps500 with fw1.49 and battery characteristics 01052 which resulted in a shortened battery operating time.If the battery is discharged and the mains supply is missing the device posts an independently energized acoustical power loss alarm which lasts at minimum for 2 minutes.The device will stop ventilating and the airway system is opened to allow spontaneous breathing.After replacement of the batteries the device was checked and found to be fine, which includes the alarm functions.A fsca has been initiated and already reported.The herein included safety note was published which the user was aware of.Although the customer was aware about that safety note, the device was not made available for battery replacement.

Event Description

Please see initial-report.

• Brand Name: INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 6154163
• MDR Text Key: 62325358
• Report Number: 9611500-2016-00374
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

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 Expiration Date: 01/01/2000
• Device Catalogue Number: 8416400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0827-2016
• Patient Sequence Number: 1