MAUDE Adverse Event Report: INTEFRATED MEASUREMENT SYSTEMS HOYER PRESENCE LIFT WITH SCALE; PATIENT LIFTER WITH SCALE

Model Number PRESENCE/SCALE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility the patient was being moved form the bed to the chair.The patient raised in the air, over the bed, when the main bolt that connects the cradle to the scale snapped.The patient fell back onto the bed.The patient did not received any injuries.Follow-up investigation confirmed no injury to the patient.Evaluation of the pictures provided by the facility shows that the top post appears to have sheared from the scale.

Manufacturer Narrative

Joerns sending the report to the manufacturer.

• Brand Name: HOYER PRESENCE LIFT WITH SCALE
• Type of Device: PATIENT LIFTER WITH SCALE
• Manufacturer (Section D): INTEFRATED MEASUREMENT SYSTEMS; elk grove village IL
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014-0000 ; 8008260270
• MDR Report Key: 3830135
• MDR Text Key: 4501295
• Report Number: 3009402404-2014-00013
• 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: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRESENCE/SCALE
• Device Catalogue Number: PRESENCE/SCALE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2014
• Distributor Facility Aware Date: 05/01/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2014
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 80 YR
• Patient Weight: 43