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

Model Number SERVO-I

Device Problem Infusion or Flow Problem (2964)

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

Event Date 04/02/2021

Event Type  malfunction  

Event Description

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

Event Description

Manufacturers ref: # (b)(4).

Manufacturer Narrative

It was reported that the ventilator failed flow transducer test during pre-use check.The ventilator logs were not provided.Our field service engineer investigated the ventilator on site and solved the issue by replacing the air gas module.The replaced part was returned for further investigation.The returned air gas module came without a nozzle unit.Simulated use testing of the air gas module passed the performed pre-use check and could not reproduce the reported failure.No abnormal found during ventilation for four days.After the ventilation, the air gas module passed another pre-use check.The reported issue could not be reproduced.Therefore, the root cause to the reported issue could not be established by this investigation.

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 11731221
• MDR Text Key: 248781926
• Report Number: 8010042-2021-00931
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• 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: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose