MAUDE Adverse Event Report: ARJO MAXISKY 600 AND 1000; LIFT

Device Problem Unintended System Motion (1430)

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

Event Type  malfunction  

Event Description

Arjo maxisky model 600 and 1000 have a significant downward drift when the emergency pull cord is activated.

• Brand Name: MAXISKY 600 AND 1000
• Type of Device: LIFT
• Manufacturer (Section D): ARJO
• MDR Report Key: 5131071
• MDR Text Key: 27832335
• Report Number: MW5056865
• Device Sequence Number: 1
• Product Code: FNG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 10/01/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1