MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRANSWARMER INF,BOX OF 6

Model Number 20421

Device Problem Output Problem (3005)

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

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation.X-no sample returned.X-review dhr.Analysis and findings: a review of the two-year history of the transwarmer inf,box of 6, product: 20421 shows similar complaints on file.There was no product returned for evaluation for over 60 days.Root cause can not be reliably determined at this time.A review of the incoming inspection records for the transwarmer, lot#: ij865, shows the products were to specification upon receipt.This lot is already depleted from the inventory.Please find attached the inspection report with the investigation, also refer to dhr review provided by the vendor.Should there be any product returned at a later time, the complaint will be reopened and updated accordingly.Coopersurgical will continue to monitor this complaint condition for any trends.Correction and/or corrective action: none.Reason: corrective action is not applicable as the affected sample was not returned for investigative analysis.No changes to the process or procedure needed at this time.Coopersurgical will continue to monitor this complaint condition for any trends.Was the complaint confirmed? no.(b)(4).

Event Description

"product didn't work when the button is activated it didn't present chemical reaction.Before, during and after use." "the newborn is in icu - intensive care unit.Is on observation in the intensive care unit." (b)(4).

• Brand Name: TRANSWARMER INF,BOX OF 6
• Type of Device: TRANSWARMER INF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 50 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 8673990
• MDR Text Key: 150996336
• Report Number: 1216677-2018-00039
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K934631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2019
• Device Model Number: 20421
• Device Catalogue Number: 20421
• Device Lot Number: IJ865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• 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