MAUDE Adverse Event Report: COOPERSURGICAL, INC. TRANSWARMER

Model Number 20421

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem Alteration In Body Temperature (2682)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"device defective on transport.Mattress did not work, appeared to have a leak.Baby's temperature decreased to 35.8 degrees celsius during transport with isolette temperature increased to max 37 degrees celsius." (b)(4).

Manufacturer Narrative

Ref e-complaint-(b)(4).Investigation: x-initiated manufacturer's investigation, x-no sample returned, x-review dhr.Analysis and findings: a review of the 2 year complaint history for the transwarmer inf,box of 6, part: 20421 shows one more similar complaint on file.The transwarmer is a purchased product.There were no product returned for evaluation, hence the complaint cannot be confirmed.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, " dhr ik147 was reviewed for any associated defects or non-conforming material reports and none were found to be present during production.There is no indication that the product will be returned for review, if it does, complaint response will be updated with findings." upon further analysis based on the follow up questions from the customer, the result can be deduced that there was a leak in the transwarmer used, which might have resulted in the drop of heat.Referring to the customer data, its an isolated incident and there were no consequences to the patient.Root cause can be deduced most possibly to be shipping/handling damage which led to the leak in the product which resulted in the drop of the heat retention capability in the product.Coopersurgical will continue to monitor this complaint condition for any trends.Correction and/or corrective action, none.No changes to the process or procedure.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.

Event Description

"device defective on transport.Mattress did not work, appeared to have a leak.Baby's temperature decreased to 35.8 degrees celcius during transport with isolette temperature increased to max 37 degrees celcius." ref e-complaint-(b)(4).

• Brand Name: TRANSWARMER
• Type of Device: TRANSWARMER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8561985
• MDR Text Key: 143665696
• Report Number: 1216677-2019-00062
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• PMA/PMN Number: K934631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 20421
• Device Catalogue Number: 20421
• Device Lot Number: IK147
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other