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

Model Number SERVO-S

Device Problems Contamination /Decontamination Problem (2895); Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

It was reported that the ventilator generated technical error code indicating a control pcb (printed circuit board) communication failure with the monitor pcb.The evaluation of received ventilator logs confirms a single occurrence of the reported technical error code.The ventilator was investigated by our field service engineer (fse).Water was traced i the air gas module.After replacing the air gas module, the ventilator passed pre-use check.The replaced air gas module is not related to the reported technical error code.The conclusion is that the reported technical error code issue was confirmed in the received ventilator logs but could not be duplicate during the investigation.The cause of the reported failure has not been established.

Event Description

It was reported that the ventilator generated technical error code indicating a control pcb (printed circuit board) communication failure with the monitor pcb.The air gas module was contaminated with water.(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: 11684574
• MDR Text Key: 245981313
• Report Number: 8010042-2021-00873
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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: 04/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1