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

Model Number SERVO-S

Device Problems Leak/Splash (1354); Output Problem (3005)

Patient Problem Death (1802)

Event Date 06/05/2020

Event Type  Death  

Event Description

The hospital reported that the patient got disconnected and alarms were not generated.The ventilator was connected back to the patient and the patient stabilized.The patient died 3 days later.The relationship between the disconnection and death has not yet been established.The patient died 3 days after the disconnection.Manufacturer's ref.#:(b)(4).

Event Description

Manufacturer's ref.# (b)(4).

Manufacturer Narrative

The investigation has been completed.No parts were replaced therefor the investigation consists of findings of our field service engineer (fse) who examined the ventilator, evaluation of the ventilator¿s logs and the information from the facility.The fse found the ventilator functioning normally and no parts were replaced.The evaluation of the ventilator¿s logs confirm the occurrence of the reported disconnection which at most lasted 14 minutes but the logs also show that the ventilator detected the situation and generated appropriate alarms contrary to what was reported.The disconnection occurred after 8 days of ventilation and after the reconnection, ventilation continued for a further 3 days.According to the hospital the disconnection was resolved immediately and the patient stabilized.The conclusion in the matter is that the disconnection occurred and the ventilator detected the disconnection and alarmed accordingly for the situation.There was no ventilator malfunction but a disconnection which is a mechanical detachment not caused by the ventilator.The ventilator detected it and alarmed accordingly for the situation.What caused the disconnection is unknown but hospital staff detected the disconnection and connected the ventilator back again to the patient whereby the patient stabilized.The initial information was that the ventilator did not cause or contribute to the final patient outcome but this has not been confirmed.

• Brand Name: SERVO-S
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10232926
• MDR Text Key: 197570806
• Report Number: 3013876692-2020-00038
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Date Report Sent to FDA: 12/03/2020
• Distributor Facility Aware Date: 12/01/2020
• Device Age: 72 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 25 YR