MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. WARMING CABINETS; WARMER, IRRIGATION SOLUTION

Model Number 5624

Device Problem Sharp Edges (4013)

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

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by the manufacturing site.Device not returned to manufacturer.

Event Description

On 25th february, 2020 getinge became aware of an issue with warming cabinets 5624.As it was stated, the sharp edges of shelves contributed to staff body cuts during loading / unloading cabinets.There was no information provided if employees needed medical intervention however, we decided to report the issue based on the potential as such situation may lead to serious injury or worse.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with warming cabinets 5624.As it was stated, the sharp edges of shelves contributed to customer staff body cuts during loading / unloading cabinets.There was no information provided if employees needed medical intervention however, we decided to report the issue based on the potential as such situation may lead to serious injury or worse.When reviewing reportable events for this type of issues we were not able to find any similar reportable complaints where the sharp edges of shelves led to customer personnel receiving skin cuts.When the event occurred, the device according to subject matter expert information did meet its specification.The provided information did not indicate that the device was being used for patient treatment when the event took place.Based on performed root cause analysis we conclude that the personnel got cut during using the warming cabinets due to improper usage of warming cabinets, namely lack of protective clothing and overloading the warming cabinets.We currently do not have any information that would warrant further action towards the devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.As device is no longer manufactured, no further actions towards device manufacturing will be provided.

• Brand Name: WARMING CABINETS
• Type of Device: WARMER, IRRIGATION SOLUTION
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• MDR Report Key: 9769494
• MDR Text Key: 217439408
• Report Number: 3012068831-2020-00002
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5624
• Device Catalogue Number: SZ5624XBR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other