MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-U; VENTILATOR, CONTINUOUS, FACILITY USE

Catalog Number 6694800

Device Problems No Display/Image (1183); Decrease in Pressure (1490); Failure to Read Input Signal (1581); Communication or Transmission Problem (2896)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The manufacturer report # for this event is 8010042-2019-00154.

Event Description

It was reported that while the ventilator was connected to a patient, it started alarming peep low, pressure delivery restricted and later displayed a technical error indicating a communication error.The right hand of the screen was blank and the screen was irresponsive to touch.The clinicians noticed that the patient was not being ventilated.Stoppage of ventilation was confirmed by the respiratory therapist by disconnecting the circuit from the patient.The patient¿s sao2 dropped to 66%.The patient was immediately removed from the ventilator and ventilated with 100% fio2 resuscitator bag and saturation went back to normal.The final patient outcome was no harm.Fda reference#: mw5084320.(b)(4).

Event Description

Fda reference#: mw5084320.Manufacturer reference#: (b)(4).Importer reference #:(b)(4).The manufacturer report # for this event is 8010042-2019-00154.

Manufacturer Narrative

The onsite investigation of the ventilator after the event found no fault and the investigation of the returned control cable did not reproduce the problem.The evaluation of logs confirms the occurrence of the reported technical error but there was no evidence of stop of ventilation.The other mentioned peep low and pressure delivery restricted alarms, which indicate leakage, patient circuit disconnected and finally loss of gas supply, were not visible on the screen but these lead to less or no gas to the patient.These were the most probable cause of the inadequate ventilation of the patient.The conclusion in the matter is that data communication to the panel ceased which was described as the screen being unresponsive.The technical error was displayed on screen but further update of the screen with new information or making changes were not possible due to this communication failure.However, the ventilator was all along working and alarming but the communication issues prevented the correct alarms to be shown on the screen.The inadequate ventilation to the patient was due to leakage and the loss of gases to the ventilator.It has not been determined whether the patient circuit disconnections alarms were due to excessive leakage.Loss of gas supply to the ventilator, leakage or patient circuit disconnection will result in less or no gases delivered to the patient.The cause of the technical error has not been determined.

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8416633
• MDR Text Key: 138821397
• Report Number: 3013876692-2019-00003
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K151814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2020
• Distributor Facility Aware Date: 02/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention