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

Model Number SERVO-N

Device Problem Output Problem (3005)

Patient Problems Bradycardia (1751); Cardiopulmonary Arrest (1765); Low Oxygen Saturation (2477)

Event Date 06/09/2020

Event Type  Injury  

Event Description

It was reported that the ventilator shutdown while it was connected to the patient and the patient went into cardiopulmonary arrest.The patient's bedside monitor alarmed with low heart rate and saturations.Cpr was started on the patient and heart rate returned to normal.The patient¿s outcome was considered to be in a stable condition.Manufacture's ref.#: (b)(4).

Manufacturer Narrative

Our field service engineer (fse) found technical errors indicating a power error and an open safety valve in the device logs on the reported date of event the fse reproduced the fault during troubleshooting and replaced the expiratory channel printed circuit board assembly (pcba) according to the recommendations in the service manual.After repair, the ventilator passed four days of simulated test ventilation and was returned to clinical usage after passed functional and safety tests to factory specifications.The evaluation of the received logs from the ventilator showed the occurrence of a technical error code indicating an open safety valve that was immediately followed by a second one indicating a power error.These two were followed by clinical alarms that indicated that the ventilator had stopped ventilating the patient as was reported.The returned expiratory channel pcba was installed in a reference ventilator for simulated use testing.The expiratory channel pcba failed immediately with the reported technical error code generated.Electrical measurements on the expiratory channel pcb showed that a capacitor in the pull magnet supply circuit was shorted-circuited, which caused the safety valve to be in an open state.A failure in the pull magnet supply circuit during ventilation may lead to stop of ventilation if the safety vale is not in its predetermined state.Occurrence of this failure will lead to activation of technical error codes and high priority alarms.The fault will be detected during pre-use check if it is present during start-up.The conclusion in this matter is that the reported issue was caused by a short-circuited capacitor on the expiratory channel pcba, which is part of the safety valve function.

Event Description

Manufacture's ref#: (b)(4).

• Brand Name: SERVO-N
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10199867
• MDR Text Key: 196572820
• Report Number: 3013876692-2020-00033
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-N
• Device Catalogue Number: 6688600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2021
• Distributor Facility Aware Date: 09/08/2021
• Device Age: 30 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening