MAUDE Adverse Event Report: PENNER MANUFACTURING, INC. CASCADE TRANSFER LIFT

Model Number 383000-1L

Device Problems Labelling, Instructions for Use or Training Problem (1318); Inadequate or Insufficient Training (1643); Device Handling Problem (3265)

Patient Problems Head Injury (1879); Concussion (2192)

Event Date 04/17/2015

Event Type  Injury  

Manufacturer Narrative

Device was inspected on 04/24/2015 and found to be in good condition.Interviews were conducted along with in house training on lift transfer.Employees were trained to use the brakes and all supplied belts during use with residents.Prior to inspection additional safety belts were ordered and rec'd by facility.Both the maintenance supervisor and the director of nursing both said that they believed that the belts were not being used at the time of the incident.It was also discussed that because of the size of the resident that more than one cna should be helping because one isn't enough to help just due to the size of a (b)(6) pound resident and the cna who is just over 5' and just over 100 pounds.

Event Description

Resident had just been given a bath and was taken out of the tub by the cna and resident went to reach for a towel to help cna dry him off and resident fell forward out of transfer and hit head on floor of bathing room.Resident was taken to the emergency room and evaluated.It was discovered that the resident had a concussion and a black eye.

• Brand Name: CASCADE TRANSFER LIFT
• Type of Device: CASCADE TRANSFER LIFT
• Manufacturer (Section D): PENNER MANUFACTURING, INC.
• Manufacturer Contact: patrick wall ; 101 grant st; aurora, NE 68818 ; 4026945003
• MDR Report Key: 4990447
• MDR Text Key: 23965959
• Report Number: 1922538-2015-00001
• 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: Manufacturer
• Source Type: company representative
• Reporter Occupation: Not Applicable
• Remedial Action: Inspection
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 383000-1L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2015
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 136