MAUDE Adverse Event Report: GETINGE SOURCING, LLC BLANKET WARMING CABINET; WARMER, IRRIGATION SOLUTION

Model Number GET2060

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 08/30/2021

Event Type  malfunction  

Event Description

Staff member was placing items in the warmer and received a cut on his finger.The warmer shelves have holes to allow air circulation and the edges of the holes are extremely sharp.We have had two previous staff injuries on the older model of the warmer from the same issue.No patients were involved.Manufacturer response for warming cabinet, (brand not provided) (per site reporter) manufacturer is looking into possible solutions.

• Brand Name: BLANKET WARMING CABINET
• Type of Device: WARMER, IRRIGATION SOLUTION
• Manufacturer (Section D): GETINGE SOURCING, LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 12553992
• MDR Text Key: 274056823
• Report Number: 12553992
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/24/2021

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
• Device Model Number: GET2060
• 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: 09/24/2021
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other