MAUDE Adverse Event Report: SUZHOU MECCAN IMP.& EXP CO., MCKESSON; LARYNGEAL MASK

Model Number 159-003

Device Problem Deflation Problem (1149)

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

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

All samples tested did not show sign of deflation.The mask cusion was able to maintain pressure for 4 hours before the test was discontinued.All samples were placed under water for 15 seconds and observed for air escaping from any location on the device and no air was identified leaking.The devices all exhibited no obvious signs of visual defects.

Event Description

The customer alleges that "the mask deflates intermittently during procedures." no other details were provided and no patient injury/harm reported.

• Brand Name: MCKESSON
• Type of Device: LARYNGEAL MASK
• Manufacturer (Section D): SUZHOU MECCAN IMP.& EXP CO.,; 12 east chunshen lake road; xiangcheng district; suzhou, china
• MDR Report Key: 9770521
• MDR Text Key: 198535626
• Report Number: 1314417-2020-00013
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 159-003
• Device Lot Number: 20180701
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1