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

Model Number SERVO-I

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Event Description

It was reported that the support arm broke during patient treatment.There was no patient harm.Manufacturer ref.#: (b)(4).

Manufacturer Narrative

Our fse (field service engineer) was not on-site since the customer did not request any service and fixed the arm by themselves.According to received information; the support arm broken, due to excessive force.We have not been provided any picture or detailed information about this case such as; from which part the support arm was broken.Therefore we cannot further investigate the reported issue.Due to lack of information the root cause could not been found but most probably the support arm had been exposed to a force that it could not been able to sustain.

Event Description

Manufacturer 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: 8775518
• MDR Text Key: 150612659
• Report Number: 8010042-2019-00477
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 06/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1