MAUDE Adverse Event Report: LIKO AB VIKING L; MOBILE PATIENT LIFTING SYSTEM, BATTERY-POWERED

Model Number 2040044

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

The hrc technician visited the site and was informed the customer had repaired the lift.The hrc technician found no fault with the lift.At this time it is unknown what part was repaired on the lift.A follow up site inspection to gather additional information regarding the event is pending.Investigation findings will be submitted in a supplemental report.

Event Description

The customer alleged that one of the hooks snapped while lifting a patient.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This report was filed in our complaint handling system as (b)(4).

Manufacturer Narrative

Viking l and xl mobile lifts are two versatile lift models intended mainly for use in health care, intensive care and rehabilitation.Viking l and xl mobile lifts are intended for heavier patients.Both models are excellent aids in daily transfers of adults and bariatrics, for instance, lifting to and from wheel chair, bed, toilet and floor.A viking¿ mobile lift equipped with the viking¿ armrest accessory can be used for gait training.Horizontal lifting can also be performed in combination with a recommended liko¿ stretcher accessory.Follow up with the customer confirmed that the clip at the end of the slingbar was broken.However when the hrc technician attended and couldn't find a fault, they been told someone had been in and fixed it.It is believed that the clip had come off without damage and someone on the ward had put it back on before the hrc technician attended.Based on information provided by the customer, the event was likely due to use error/ device misuse in sling application to the lift.Prevention for such an event is outlined in the ifu and noted above.There was no observed malfunction or patient injury and the reported event could be contributed to a user error.Hillrom does not consider this to be a reportable event.

Event Description

The customer alleged that one of the hooks snapped while lifting a patient.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This report was filed in our complaint handling system as (b)(4).

• Brand Name: VIKING L
• Type of Device: MOBILE PATIENT LIFTING SYSTEM, BATTERY-POWERED
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17180565
• MDR Text Key: 317727074
• Report Number: 8030916-2023-00048
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2040044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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