MAUDE Adverse Event Report: HILL-ROM INC. AIR-SHIELDS IICS-90 INFANT; WARMER, INFANT RADIANT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2016

Event Type  malfunction  

Event Description

A neonate was placed on the radiant warmer (hill-rom) and the warmer malfunctioned.It would not increase and did not maintain the heater temperature and hold the infant's temperature.The infant was moved to another radiant warmer.There was no harm to the infant.Manufacturer response for neonate radiant warmer (air-shields), air-shields radiant warmer (per site reporter): unknown.

• Brand Name: AIR-SHIELDS IICS-90 INFANT
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): HILL-ROM INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 5983023
• MDR Text Key: 55821928
• Report Number: 5983023
• Device Sequence Number: 1
• Product Code: FMT
• 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: 08/16/2016,09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• 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: 08/16/2016
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1