MAUDE Adverse Event Report: PENNER MANUFACTURING, INC. CASCADE PATIENTTRANSFER LIFT SYSTEM; PATIENT LIFT

Model Number 383000-1

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 07/12/2014

Event Type  Injury  

Event Description

As reported by the facility to penner mfg: the pt was being lowered in the lift (without the required and provided belt) when the pt became restless or impatient as described to us.The pt then leaned forward in the chair to get out and fell about a foot to the floor.She was assessed and found to have broken her hip.According to our safe operations manual the belt was not used with the pt while she was in the chair.Also according to our safe operation manual the pt is to be assessed to make sure pt is suitable for transfer.According to the reporting facility the belt migrated away from the chair at some point.

• Brand Name: CASCADE PATIENTTRANSFER LIFT SYSTEM
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): PENNER MANUFACTURING, INC.; 102 grant st.; aurora NE 68818
• Manufacturer (Section G): PENNER MANUFACTURING, INC.; 102 grant st.; aurora NE 68818
• Manufacturer Contact: 102 grant st.; aurora, NE 68818
• MDR Report Key: 4320524
• MDR Text Key: 5132814
• Report Number: 1922538-2014-00002
• 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: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 383000-1
• Device Catalogue Number: 02091145401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 5 YR
• Date Report to Manufacturer: 09/04/2014
• Date Manufacturer Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR