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

Model Number SERVO-I

Device Problems Infusion or Flow Problem (2964); Output Problem (3005)

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

Event Date 04/08/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator failed internal leakage and flow transducer test during pre-use check.There was no patient involvement.Manufacturer ref.#: (b)(4).

Manufacturer Narrative

The ventilator was investigated at site by our field service engineer.The o2 gas module was found faulty after replacement, the ventilator passed all functional and safety tests and was cleared for clinical use.The replaced o2 gas module and the logs from the ventilator were not sent to our investigation.Therefore further investigation was not possible and the root cause for the defective o2 gas module could not been identified.

Event Description

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

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11731870
• MDR Text Key: 248782912
• Report Number: 8010042-2021-00943
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2021
• Patient Sequence Number: 1