MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-U; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number SERVO-U

Device Problem Disconnection (1171)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

It was reported that the nava edi catheter was disconnected during kangaroo care.The patient had bradycardia and the saturation decreased to unknown level.Final patient outcome was no injury.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

It was reported that the nava edi catheter was displaced during kangaroo care.No parts or ventilator logs were returned.Further information was requested but no response has been received.Due to the limited information provided, no investigation has been possible.Therefore the root cause of the reported event has not been determined.H3 other text : 4119.

Event Description

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

• Brand Name: SERVO-U
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 16876407
• MDR Text Key: 314640197
• Report Number: 3013876692-2023-00022
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2023
• Distributor Facility Aware Date: 08/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2023
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening