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

Device Problems Connection Problem (2900); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

Event Type  malfunction  

Event Description

A new blanketrol iii machine was ordered for one of our icus for our post-arrest care protocol.The equipment was delivered to the hospital and an esophageal/rectal temperature probe was sent that did not connect to the unit.Historically, our probes have had a male/female connector on the end.The probe supplied was an rj connector.There was no notice, warning, or communication that the manufacturer was changing the connections to any of the equipment associated with the machine.Had we needed to use this piece of equipment emergently for a patient, it would not have been ready for use.There was no harm to a patient.Manufacturer response for blanketrol iii, blanketrol iii (per site reporter).Our biomedical engineering team contacted csz about this issue.We understand that the manufacturer is moving to the rj connector for their disposable probes, but there was no notification, communication, or other notice to the organization that there would be a change.

Event Description

A new blanketrol iii machine was ordered for one of our icus for our post-arrest care protocol.The equipment was delivered to the hospital and an esophageal/rectal temperature probe was sent that did not connect to the unit.Historically, our probes have had a male/female connector on the end.The probe supplied was an rj connector.There was no notice, warning, or communication that the manufacturer was changing the connections to any of the equipment associated with the machine.Had we needed to use this piece of equipment emergently for a patient, it would not have been ready for use.There was no harm to a patient.Manufacturer response for blanketrol iii, blanketrol iii (per site reporter) our biomedical engineering team contacted csz about this issue.We understand that the manufacturer is moving to the rj connector for their disposable probes, but there was no notification, communication, or other notice to the organization that there would be a change.

Event Description

A new blanketrol iii machine was ordered for one of our icus for our post-arrest care protocol.The equipment was delivered to the hospital and an esophageal/rectal temperature probe was sent that did not connect to the unit.Historically, our probes have had a male/female connector on the end.The probe supplied with the new blanketrol was an rj connector, and we were unable to use this device.Our hospital did not order the device with the different rj connection, and expected to receive an identical blanketrol with the same connections as our current machine.There was no notice, warning, or communication that the manufacturer was changing the connections to any of the equipment associated with the machine.Following a conversation with the manufacturer, they quickly shipped another machine with the proper connections for our hospital to use and no further incidents have been identified.Had we needed to use this piece of equipment, with the different connector, emergently for a patient we would have been unable to do so.Manufacturer response for blanketrol iii, blanketrol iii (per site reporter).Our biomedical engineering team contacted csz about this issue.We understand that the manufacturer is moving to the rj connector for their disposable probes, but there was no notification, communication, or other notice to the organization that there would be a change.

• Brand Name: BLANKETROL III
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, LLC; 12011 mosteller rd.; cincinnati OH 45241
• MDR Report Key: 8288382
• MDR Text Key: 134495193
• Report Number: 8288382
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2019

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/27/2019; 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20075 DA