MAUDE Adverse Event Report: COOPERSURGICAL, INC. INCA 9F COMPLETE SET

Model Number 44-2709DF

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).

Event Description

"our babies, whether tiny or big, are usually covered in some form of " birth process." may be blood or a white, cheese like coating.The fp hats are not easy to get on a dry baby at times in nicu.I quickly found out that trying to get a hat without much stretch on a wet, gooey head is what i call a failure.Baby was fine with my quick trial because i first put inca setup on to stabilize pt.But with inca setup falling apart twice i thought good time to try.".

• Brand Name: INCA 9F COMPLETE SET
• Type of Device: INCA 9F COMPLETE SET
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 75 corporate drive; trumbull, CT 06611
• MDR Report Key: 8460172
• MDR Text Key: 141024761
• Report Number: 1216677-2019-00140
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 44-2709DF
• Device Catalogue Number: 44-2709DF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1