MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PALLAS; ANESTHESIA UNITS

Catalog Number 8608500

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  malfunction  

Event Description

It was reported that the ventilator failed during use.There was no patient injury reported.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that the ventilator failed during use.There was no patient injury reported.

Manufacturer Narrative

At the time reported, the log file showed a sporadic failure of the inspiratory pressure sensor (pz) on the vgc analog circuit board.The device reacted as specified with an autonomous shutdown of the ventilator and gave an acoustic and visual alarm for ventilator fail, while switching autonomously to manual ventilation (man/spont).Gas dosing and monitoring are not affected.

• Brand Name: PALLAS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17972917
• MDR Text Key: 327033165
• Report Number: 9611500-2023-00372
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8608500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2009
• 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