MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 8668

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to the manufacturer.

Event Description

On 19th july, 2023 getinge became aware of an issue related to the washer disinfectors with the model name 8668.As it was stated customer removed the lower panel below the door after an error code appeared.While removing the stainless steel panel the customer cut himself and required medical attention.The injury was classified as serious as two stitches were needed on the cut hand.

• Brand Name: 86-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer Contact: ljungadalsgatan 11; vaxjo
• MDR Report Key: 17406848
• MDR Text Key: 319920069
• Report Number: 3012092534-2023-00002
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2023
• Distributor Facility Aware Date: 07/19/2023
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2023
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male