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

Model Number SERVO-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/14/2020

Event Type  Death  

Event Description

It was reported that the patient expired while on ventilator.The user facility does not believe that there was any ventilator malfunction, but requests an examination.(b)(4).

Manufacturer Narrative

The ventilator was investigated by our field service engineer.The ventilator passed all safety and functional tests and was cleared for clinical use.An event log in txt-format was provided.The patient reportedly expired on august 14, 2020 at 2:35 pm.The logs does not contains any shutdowns or technical error codes at that time.There are no indications of a ventilator malfunction.From the user, there are no allegations of a ventilator malfunction or that the ventilator contributed to the patient¿s death.

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: 10527852
• MDR Text Key: 206740856
• Report Number: 3013876692-2020-00047
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2021
• Distributor Facility Aware Date: 03/19/2021
• Device Age: 138 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2021
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 DA