MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR MODELS 5524, 5618, 5624 WARMING CABINET; WARMER, IRRIGATION SOLUTION

Model Number 5624

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 01/04/2020

Event Type  malfunction  

Event Description

Staff have been cut by sharp edges on the shelves of warmers that have holes punched out for circulation.During regular stocking or removing of items they can cut staff.Staff was cut on a model 5624.~3 weeks later, staff was cut on a different 5624 unit.Hospital has large inventory of warmers.4 were checked in icn where incidents happened and all were found to have sharp edges around the holes on the underside of all three shelves in each warmer.Manufacturer response for warmer, (brand not provided) (per site reporter).Getinge plans to come to the hospital next week to look at the shelves.

• Brand Name: MODELS 5524, 5618, 5624 WARMING CABINET
• Type of Device: WARMER, IRRIGATION SOLUTION
• Manufacturer (Section D): MAQUET CARDIOVASCULAR; 45 barbour pond dr; wayne NJ 07470
• MDR Report Key: 9779376
• MDR Text Key: 181777081
• Report Number: 9779376
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2020,02/20/2020

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: Health Professional
• Device Model Number: 5624
• 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: 02/21/2020
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other