MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVAPLUS INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Model Number V11443-012B

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2021

Event Type  malfunction  

Event Description

Staff have experienced the instant hot packs not being hot.It seems like we get a bad batch from time to time.Now this might not be a patient safety issue as the packs do not get hot but they also are not performing as expected.

• Brand Name: NOVAPLUS INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12287258
• MDR Text Key: 265368096
• Report Number: 12287258
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V11443-012B
• Device Catalogue Number: V11443-012B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1