MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 533HCMC; STERILIZER, STEAM

Device Problem Leak/Splash (1354)

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

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is still being investigated by manufacturing site.Other text : device not returned to manufacturer.

Event Description

On (b)(6), 2019 getinge became aware of an issue with one of steam sterilizers ¿ 533hcmc.As it was stated by the customer, in the middle of the cycle the steam started to burst out and filled the room.There was no injury reported however we decided to report the issue based on the potential as any unexpected steam leak for parts available for the user might be a source of injury.

Manufacturer Narrative

The manufacturer was incorrectly chosen therefore, the number of the report was incorrect.Reporting will be continued under manufacturer report number 3012068831-2019-00011.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: 533HCMC
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• Manufacturer (Section G): PASCAL JAY - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; 0332382587
• MDR Report Key: 9070136
• MDR Text Key: 175198917
• Report Number: 9710055-2019-00271
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/16/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1