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

Model Number SERVO-S

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2019

Event Type  malfunction  

Event Description

It was reported that the support arm of the ventilator broke.There was no patient involvement.(b)(4).

Event Description

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

Manufacturer Narrative

The customer did not request any service and the support arm was replaced by the hospital staff.No parts or photos were received for our further investigation.Due to lack of information, we can not determine the root cause of the reported event.However, the support arm is a casting and it most probably developed a crack at an earlier occasion either by overloading or impact and this led to the reported breaking.H3 other text: 4112.

• Brand Name: SERVO-S
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9389745
• MDR Text Key: 174343302
• Report Number: 8010042-2019-00868
• 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: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 11/28/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1