MAUDE Adverse Event Report: PHILLIPS MEDICAL SYSTEMS INFA-THERM DISPOSABLE INFANT TRANSPORT MATTRESS; PACK, HOT OR COLD, DISPOSABLE

Lot Number 121919

Device Problems Defective Device (2588); Activation, Positioning or Separation Problem (2906)

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

Event Date 01/19/2020

Event Type  malfunction  

Event Description

Obtained disposable infant transport mattress and popped disk to activate warming gel.Disk popped but did not crystalize and provide heat.

• Brand Name: INFA-THERM DISPOSABLE INFANT TRANSPORT MATTRESS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): PHILLIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9699479
• MDR Text Key: 178969180
• Report Number: 9699479
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 121919
• 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: 01/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1