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

Catalog Number 8416400

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Hypoventilation (1916); Decreased Respiratory Rate (2485)

Event Date 12/16/2015

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

It was reported, that the customer filed a medwatch report with the fda which documented the following event: ventilator was on a patient and just stopped breathing and alarmed with a device failure alarm that could not be cleared.The only way to stop alarm was to turn the ventilator off.The nurses and technicians were forced to swap out the ventilator with another to put back on the patient.The customer indicated in the medwatch report that an adverse event had occurred (death).Drager quality followed up with the customer to determine if the statement was correct.The customer stated that the patient death did not result but they considered the event life threatening.The customer also stated that no harm was done to the patient due to the error.

Manufacturer Narrative

The device log was downloaded and analyzed.The analysis revealed that the ventilator performed several reboots, beginning on (b)(6) 2015 at 4:19am.This behavior was caused by a malfunction of the central pcb, the so called therapy control unit.The device internal monitoring had recognized data inconsistency and therefore triggered these reboots to restore the data base for ventilation.As this was a hardware failure, the reboots were not successful and were repeated 7 times within 16 minutes.Each reboot needs about 7 seconds.After a further period without reboots the device finally stopped ventilation at 5:23am with alarm.During a reboot and after stop of ventilation as well the breathing system is automatically opened to atmosphere in order to allow breathing efforts of the patient.This is accompanied by alarm.The failure rate of the concerned pcb is low and within the accepted range.The manufacturer comes to the conclusion that the device behaved as specified in this failure case.

Event Description

Please see initial-report.

• Brand Name: INFINITY ACS WORKSTATION CC
• Type of Device: VENTILATOR, 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: 5485656
• MDR Text Key: 40134280
• Report Number: 9611500-2016-00058
• 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: 04/08/2016

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: 02/08/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2010
• 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