MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRANSWARMER

Model Number 20421

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/28/2015

Event Type  malfunction  

Manufacturer Narrative

The device involved in the complaint will be returned.Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow up report will be filed (b)(4).

Event Description

Reference medwatch mw5061596.(b)(4)."transwarmer would not activate/warm.Had to grab another that did activate to warm mattress for preemie baby.This is the 2nd time this has happened with this exact product.Staff didn't keep first transwarmer for reporting info.".

Manufacturer Narrative

(b)(4).Investigation: initiated manufacturer's investigation.No sample returned.Review dhr.Inspect returned samples.Inspect stock product.Analysis and findings: pristech investigation.Response received from supplier.Supplier found that review of the batch records indicated all samples met requirements.Potential cause for not achieving 102-105 f could be product was activated at a temperature below recommendation and therefore the mattress felt cooler than normal.Corrective actions: correction and/or corrective action: continue to monitor.Corrective action level 4: train personnel.None.Reason: no changes to process or procedures.Was the complaint confirmed? yes.Review and closure: capa required? recommended continuous improvement program (cip) complaint closure letter required? ncmr issued? other regulatory action needed: preventative action activity: reviewed.Trend and monitor to cip.

Event Description

Reference medwatch mw5061596.(b)(4)."transwarmer would not activate/warm.Had to grab another that did activate to warm mattress for preemie baby.This is the 2nd time this has happened with this exact product.Staff didn't keep first transwarmer for reporting info.".

• Brand Name: TRANSWARMER
• Type of Device: TRANSWARMER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5811761
• MDR Text Key: 51008407
• Report Number: 1216677-2016-00050
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 20421
• Device Catalogue Number: 20421
• Device Lot Number: IJ459
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2015
• 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