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 03/29/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator had o2 leakage.There was no patient harm.Manufacturer ref.#: (b)(4).

Manufacturer Narrative

It was reported that the ventilator had o2 leakage.The service engineer replaced an oxygen hose.The ventilator was returned to the customer after passed functional tests.No part was returned.This concerns the gas supply outside the ventilator.The gas supply pressure is checked during pre-use check.If the o2 gas supply fails during ventilation, low o2 levels to the patient may follow and alarms will be raised if set alarm limits are violated.The conclusion is that an o2 hose in the ventilator gas supply was replaced, which resolved the problem.No technical ventilator malfunction was found.

Event Description

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

• Brand Name: SERVO-S
• 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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11723858
• MDR Text Key: 247252698
• Report Number: 8010042-2021-00922
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2009
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1