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 Consequences Or Impact To Patient (2199)

Event Date 12/25/2020

Event Type  malfunction  

Event Description

It was reported the gas module of the ventilator was broken.There was no patient harm.(b)(4).

Event Description

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

Manufacturer Narrative

It was reported that the gas module of the ventilator was broken.According to the service report the defected gas module couldn't not read the inlet air pressure that coming from the hospital's gas supply system and it failed with gas supply test during the pre-use check.The evaluation of the provided device logs confirms that the air gas module was reading low pressure and failed with gas supply test.The fan of the reported machine was clogged with dust.The field service engineers cleaned the fan and replaced the gas module to resolve the issue.However, the replaced gas module has not been returned for investigation.As the defective gas module has not returned for investigation, it was not possible to determine the root cause for the reported issue.

• Brand Name: SERVO-S
• 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: 11213804
• MDR Text Key: 228169415
• Report Number: 8010042-2021-00120
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2014
• 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