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

Model Number SERVO-I

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

Patient Problem Death (1802)

Event Date 11/12/2020

Event Type  Death  

Event Description

It was reported that the patient died during ventilation therapy.No information was provided whether there was a ventilator malfunction.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

The user facility has confirmed that the patient death was not attributed to the ventilator.No service or investigation of the ventilator has been requested and no ventilator logs have been provided.The user facility performs service by themselves.The ventilator has reportedly been returned to clinical use.There are no indications that a ventilator malfunction in any way caused or contributed to the death of the patient.H3 other text : 4117.

Event Description

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

• Brand Name: SERVO-I
• 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: 10991397
• MDR Text Key: 220908329
• Report Number: 3013876692-2020-00070
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• 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: 06/02/2022
• Distributor Facility Aware Date: 06/02/2022
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2022
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death