MAUDE Adverse Event Report: TRANSDUCER BROKE OFF SET; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Lot Number UNKNOWN

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

Event Type  malfunction  

Event Description

Patient transported back from operating room with anesthesia and ent.When patient arrived in room, left ventricular transducer was broken off.Left ventricular was clamped for transport and remains clamped.Neurosurgery peds notified that the entire left ventricular needs to be replaced down to the surgical site.Transducer part of ventricular device broke off, rn immediately clamped line and paged neurosurgeon who came to replace setup.Manufacturer response for ventriculostomy, transducer broke off set (per site reporter).Manufacturer sent a device correction notification letter and we are no longer using these devices.

• Brand Name: TRANSDUCER BROKE OFF SET
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• MDR Report Key: 8975077
• MDR Text Key: 157143058
• Report Number: 8975077
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2019,07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2019
• Date Report to Manufacturer: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6570 DA