MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION NC; VENTILATORS, INTENSIVE CARE, NEONATAL/PEDIATRIC

Model Number 8417400

Device Problems Failure to Deliver (2338); No Pressure (2994); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but is not yet concluded.Results will be provided in a follow up report.

Event Description

It was reported that while using the device, the pressure measurement was inaccurate and an alarm was generated.Subsequently the ventilation has stopped with a device malfunction alarm.No patient consequences reported.

Event Description

Please refer to the initial report.

Manufacturer Narrative

The device was tested onsite by dräger service and the log file was provided to the manufacturer for a detailed analysis.During a functional test the device behaved as specified and no problem was found.The logged entries show that the safety software of the device detected a significant difference in expiratory and inspiratory pressure on july 14th, and alarmed ¿pressure measurement inaccurate¿ and ¿device failure¿ as a result.There is no indication of a technical malfunction in the log file.Based on the results of the investigation it is likely that the root cause of the event was an issue within the breathing circuit.The device reacted as specified to a significant difference in expiratory and inspiratory pressure with accompanying visual and audible alarm messages.A pressure release of the pneumatic system as a safety measure was performed to allow for spontaneous breathing.However, manual ventilation with an alternate device may be considered necessary.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: INFINITY ACS WORKSTATION NC
• Type of Device: VENTILATORS, INTENSIVE CARE, NEONATAL/PEDIATRIC
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10394750
• MDR Text Key: 202590257
• Report Number: 9611500-2020-00283
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675250418
• UDI-Public: (01)04048675250418(11)160614(17)160614(93)8417400-14
• Combination Product (y/n): N
• PMA/PMN Number: K093632
• 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: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8417400
• Device Catalogue Number: 8417400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1