MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRANSWARMER

Model Number 20421

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.Ref e-complaint (b)(4).

Event Description

Per e-mail report- mattress did not heat up upon using.Expiration date was 2010 on (b)(4) mattress was not working and appeared to have a leak.Ref e-complaint (b)(4).

Manufacturer Narrative

Ref e-complaint (b)(4).Investigation: x-review dhr, x-inspect returned samples.Analysis and findings: a review of the 2 year complaint history for the transwarmer inf,box of 6, part: 20421 shows some similar complaints on file.The transwarmer is a purchased product.The expiration date on the returned product is identified to be 2020-10.Refer to attached images of the returned product.The returned product was sent back to the vendor for further analysis.A review of the incoming inspection records for the transwarmer inf for lot ik147 shows the products were to specification upon receipt.The complaint condition was assessed by vendor.As per the vendor assessment, pouch was received activated with no identified leaks.Item was boiled to return to ready to use state and was allowed to cool to room temperature.During cooling process, the item self activated before reaching ready to use state.It is in this instance when a small tear was located at the bottom left side seal, a full separation of the material adjacent to the seal.Root cause of the issue was ascertained to be incorrect handling because this kind of damage requires significant force such as dropping the case, etc.Complete vendor analysis is attached for reference.Coopersurgical will continue to monitor this complaint condition for any trends.Correction and/or corrective action: none.No changes to the process or procedure.Coopersurgical will continue to monitor this complaint condition for any trends.Was the complaint confirmed? yes.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

Per e-mail report: mattress did not heat up upon using.Expiration date was 2010 on ah# 195802, ah#195804 mattress was not working and appeared to have a leak.Ref e-complaint (b)(4).

• Brand Name: TRANSWARMER
• Type of Device: TRANSWARMER
• 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 ; 50corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 8604724
• MDR Text Key: 144977745
• Report Number: 1216677-2019-00078
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K934631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

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 Expiration Date: 10/31/2020
• Device Model Number: 20421
• Device Catalogue Number: 20421
• Device Lot Number: IK147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• 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