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

Model Number SERVO-S

Device Problem Decrease in Pressure (1490)

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

Event Date 03/30/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator had a low oxygen pressure.The patient involvement is unknown.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

The ventilator was investigated on site and the o2 gas module was replaced and returned for further investigation.No device log file has been received.The reported failure with an alarm for low inlet oxygen pressure was reproduced during simulated use testing of the returned oxygen gas module in a ventilator.A defective pressure transducer on a printed circuit board inside the gas module caused the failure.The supply pressure transducer is part of the flow measuring in the gas module.The failure of the pressure transducer leads to inaccurate gas flow regulation which will be detected during pre-use check and alarms will be activated if the failure occurs during ventilation.The manufacture date has been wrongly reported in the initial mdr and is corrected accordingly.

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
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11722828
• MDR Text Key: 247214602
• Report Number: 8010042-2021-00915
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose