MAUDE Adverse Event Report: SUNRISE MEDICAL HOYER LIFT; PATIENT LIFT

Model Number HPL-600

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Headache (1880); Pain (1994)

Event Date 06/15/2018

Event Type  Injury  

Event Description

Reporter states that a resident at approx 15:40 was transferred via hoyer lift by two employees with one standing in front of resident and the second employee behind the resident.Per reporter, while in the process of transferring resident from wheel chair to bed, the strap protecting the resident's left shoulder got loose causing the resident to fall off of the sling to the floor.Resident complained of headache and neck pain and was transferred to the er for evaluation and treatment.According to reporter, upon further evaluation, a c2 fracture was observed and resident was then admitted.Per reporter, the right sling was used as there was no defect (tear/hole) noted and did pass functionality test.The lift and sling were removed from service, pending evaluation from mfr.Reporter states that management notified mfr of the incident on (b)(6) 2018 and want fda to also be informed as well.

• Brand Name: HOYER LIFT
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): SUNRISE MEDICAL
• MDR Report Key: 7670764
• MDR Text Key: 113510862
• Report Number: MW5078282
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HPL-600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 97