MAUDE Adverse Event Report: CINCINNATI SUB- ZERO PRODUCTS, LLC BLANKETROL; SYSTEM, THERMAL REGULATING

Catalog Number 874

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2016

Event Type  malfunction  

Event Description

Small blanketrol water mattress began leaking after attached to machine, shortly after being turned on.  leak was noticed immediately, patient was not in room yet, set up was not contaminated.  mattress replaced.

• Brand Name: BLANKETROL
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): CINCINNATI SUB- ZERO PRODUCTS, LLC; 12011 mosteller rd.; cincinnati OH 45241
• MDR Report Key: 6212355
• MDR Text Key: 63503998
• Report Number: 6212355
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 874
• Device Lot Number: 745270, (01) 1 0613031 82174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 9