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

Model Number SERVO-I

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/22/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator was damaged.Patient involvement is unknown.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

Further information has been requested but no response has been received.No ventilator logs have been provided and no service on the ventilator has been requested.Information about the current status of the ventilator has not been provided.No investigation has been possible, therefore the root cause of the reported event has not been determined.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
• MDR Report Key: 11347413
• MDR Text Key: 232506816
• Report Number: 8010042-2021-00422
• 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: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1