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

Model Number SERVO-S

Device Problem Output Problem (3005)

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

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

During investigation on-site performed by our field service engineer presence of moisture/corrosion/liquid spill in the printed circuit board (pcb) was found.The pcb were replaced and after successful tests the ventilator was sent back in service.The pcb were not further investigated since ingress of liquid/corrosive substance on printed circuit boards can cause failure/short circuits which might lead to a ventilator malfunction.There is no information on how the liquid spill entered the ventilator or what kind of liquid spill it was.

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).

• 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: 11744493
• MDR Text Key: 248784317
• Report Number: 8010042-2021-00967
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2009
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1