MAUDE Adverse Event Report: GETINGE/MAQUET GMBH GETINGE, USA; MAGNUS HYBRID OPERATING ROOM TABLE, AC-POWERED

Model Number 118016F2

Device Problems Unintended Collision (1429); Loss of Power (1475)

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

Event Date 02/10/2019

Event Type  malfunction  

Event Description

Getinge usa operating room table at (b)(6) medical center in (b)(6) continuously shut down, thereby rendering it dangerous for patient surgeries.Patient collisions were imminent with x-ray machine, other equipment and even surgeons.The hospital refused to use the dangerous equipment and getinge didn't seem to be concerned even after my repeated alarming calls and emails.No response from getinge usa service department or manager, (b)(4).After almost 2 months of multiple requests to sales manager (b)(4) and service department manager (b)(4), there was still no response.Finally, after my repeated request i emailed (b)(4) on march 7, 2019.(i have all emails documented on this) she still ignored my request which should have been addressed within 24 hours according to fda rules.The operating room table was finally inspected by an engineer, (b)(4) on march 9th 2019 who couldn't fix the problem.The table is now in use but i never received information on how it was resolved, if at all.The internal getinge code for the product complaint is (b)(4).The product's name is magnus part #118016f2 in operating room #3 at (b)(6) medical center in (b)(6).

• Brand Name: GETINGE, USA
• Type of Device: MAGNUS HYBRID OPERATING ROOM TABLE, AC-POWERED
• Manufacturer (Section D): GETINGE/MAQUET GMBH; 45 barbour pond dr.; wayne NJ 07470
• MDR Report Key: 8768425
• MDR Text Key: 150601490
• Report Number: MW5087923
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118016F2
• Device Catalogue Number: 118016F2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other