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

Model Number SERVO-S

Device Problem Infusion or Flow Problem (2964)

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

Event Date 04/11/2021

Event Type  malfunction  

Event Description

It was reported that there was no delivered volume from the ventilator.There was no patient harm.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The ventilator was investigated by our field service engineer.The reported event could not be duplicated.The ventilator passed all functional and safety tests and was returned to customer for clinical use.No parts were replaced.Provided ventilator logs indicate alarms for excessive leakage in the patient breathing circuit or a disconnect situation; expiratory minute volume low, vt insp.Overrange and peep low.Successful pre-use checks were performed prior and after the event.The technical log does not contain any technical error codes to indicate that there was a ventilator malfunction at the time of the event.The cause of the alarms has not been determined but they were most probably due to leakage.

Event Description

Manufacturer's ref #: (b)(4).

• Brand Name: SERVO-S
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11723310
• MDR Text Key: 247252639
• Report Number: 8010042-2021-00919
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

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 Model Number: SERVO-S
• Device Catalogue Number: 6640440
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 06/09/2021
• Patient Sequence Number: 1
• Patient Age: 58 YR