MAUDE Adverse Event Report: AMBU A/S AMBU WHITESENSOR WS/RT; ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE

Catalog Number WS-00-S/RT/50

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

The release liner was dropped on a laryngeal mask, which then became a carrier for the release liner into patient's throat during intubation.User error, device malfunction did not occur.Device not returned,.

Event Description

The release liner of the electrode got stuck on a laryngeal mask, which was inserted into the patient.The patient went home and then went back to hospital at a later date to have the liner removed using a scope.

• Brand Name: AMBU WHITESENSOR WS/RT
• Type of Device: ELECTROCARDIOGRAPHIC ELECTRODE, SINGLE-USE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, ballerup DK-27 50; DA DK-2750
• Manufacturer (Section G): AMBU A/S; 6230 old dobbin lane; suite 250; columbia MD 21045
• Manufacturer Contact: sanjay parikh ; baltorpbakken 13; ballerup, ballerup DK-27-50 ; DA DK-2750 ; 7686464
• MDR Report Key: 6507576
• MDR Text Key: 73262076
• Report Number: 9610691-2017-00002
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: D150378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/24/2017,04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: WS-00-S/RT/50
• Device Lot Number: 21116S5MRT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2017
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 75