MAUDE Adverse Event Report: COVIDIEN 1180571570 THORA-SEAL II X5; BOTTLE, COLLECTION, VACUUM

Model Number 1180571570

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the tubing from the water chamber that connects to the patient keeps disconnecting.

Manufacturer Narrative

Additional information has been received which confirmed that this event was created in error.This complaint will be voided.No further reports will be forwarded.

• Brand Name: 1180571570 THORA-SEAL II X5
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 10097382
• MDR Text Key: 194327940
• Report Number: 9611018-2020-00427
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1180571570
• Device Catalogue Number: 1180571570
• Device Lot Number: 18G036FHX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/29/2020
• Patient Sequence Number: 1