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

Model Number SERVO-I

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 01/04/2021

Event Type  malfunction  

Event Description

It was reported that the user interface holder of the ventilator was broken.There was no patient involvement.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

Investigation was performed on-site by our field service engineer.The reported failure could be confirmed.A new user interface holder was mounted.The ventilator then passed all functional and safety tests and was cleared for clinical use.No parts were returned for investigation.The consequence to this kind of mechanical damage is that the user interface gets detached and in a worst case falls off the ventilator carrier.Our conclusion is that the user interface has been exposed to a mechanical force greater than it is designed to sustain.

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: 11251472
• MDR Text Key: 229348928
• Report Number: 8010042-2021-00224
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2011
• 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