MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z.O.O. GETINGE 88-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 88 TURBO

Device Problems Break (1069); Difficult to Remove (1528); Device Inoperable (1663)

Patient Problem Injury (2348)

Event Date 03/08/2017

Event Type  malfunction  

Event Description

Faulty equipment.The company getinge has installed off loaders for our washer decontaminator machines and they all to often stop working which causes employees to manually pull the racks out.You have to pull real hard to move them in which case, that is how the employee injured the shoulder / neck by pulling to unload the machine.Manufacturer response for automatic unloading station, 88 turbo washer disinfector (per site reporter): getinge has been contacted and they have tried several changes and adjustments to the auto unloaders but none of them have fixed the issue.The unloading stations keep damaging the doors on the 88 turbo machines and they keep locking up.We have 4 of them and all of these unloaders stations have the same problem.This issue still without resolution from getinge.

• Brand Name: GETINGE 88-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z.O.O.; 45 barbour pond dr.; wayne NJ 07470
• MDR Report Key: 6484931
• MDR Text Key: 72542929
• Report Number: 6484931
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 88 TURBO
• Other Device ID Number: 88 TURBO WASHER DISINFECTOR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2017
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE UNLOADING SYSTEM WAS ATTACHED TO A GETINGE 88
• Patient Outcome(s): Other