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

Model Number SERVO-U

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The humidifier holder was not investigated by our field service engineer.The humidifier holder was replaced by the healthcare facility but not returned for investigation.The event was confirmed by provided photo showing the humidifier holder arm broken.The consequence of this kind of mechanical damage is that the humidifier gets detached and, in a worst case scenario, falls off the ventilator carrier and may lead to stop of ventilation (extubation) or injury.There are no reported injuries related to this kind of breakage.The humidifier holder is intended for an active humidifier with or without a water bag, and the holder is specified and verified for a total load of 120 n (12 kg).To break the holder arm, extensive force outside intended use is needed.Our conclusion into this matter is that the humidifier holder most likely has been exposed to a mechanical force greater than it is designed to sustain.There is no ventilator malfunction.(b)(4).

Event Description

It was reported that the humidifier holder arm broke.There was no patient involvement.Manufacturer's ref #: (b)(4).

Event Description

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

Manufacturer Narrative

The humidifier holder was replaced by the healthcare facility and returned for investigation.Visual analysis confirmed the plate intended to be inserted into the rail clamp mounted on the ventilator carrier was detached from the humidifier holder arm.Due to limitations in investigating the damages in getinge lab, the humidifier holder was returned to our supplier for additional investigation.The machined and casted humidifier holder was checked for visible pores that can have an effect on the durability of the part.No anomalies that can cause lower durability/strength were noted.After casting, as a final inspection, all humidifier holders are visually checked for casting anomalies such as cracks and air pores.The supplier¿s conclusion is that the humidifier holder has been manufactured within specification and required tolerance.The humidifier holder is intended for an active humidifier with or without a water bag, and the humidifier holder is specified and verified for a total load of 120 n (12 kg).The servo-u user¿s manual states a maximum load of 5 kg.As an example, an active humidifier fisher&paykel mr850 filled with water weights 3.1 kg according to its user¿s manual.To break the holder arm, extensive force outside intended use is needed.Tests have showed that the product may withstand up to 400 n (40 kg) load downwards before deformation of the plate fastening screws occur.The consequence of this kind of mechanical damage is that the humidifier gets detached and, in a worst case scenario, falls off the ventilator carrier and may lead to stop of ventilation (extubation) or injury.There are no reported injuries related to this kind of breakage.Our conclusion into this matter is that the humidifier holder most likely has been exposed to a mechanical force greater than it is designed to sustain.

• Brand Name: SERVO-U
• 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: 11435176
• MDR Text Key: 238362505
• Report Number: 8010042-2021-00516
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180098
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-U
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose