MAUDE Adverse Event Report: BEKA HOSPITEC CARLO COMFORT GP L; MECHANICAL LIFT

Model Number 925001000

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Material Separation (1562)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Laceration(s) (1946)

Event Date 01/29/2014

Event Type  malfunction  

Event Description

While preparing to place mechanical lift over resident while in bed, lift cradle separated from lift arm and dropped onto resident and staff member causing laceration and hematoma to left eyebrow of resident and possible fracture of staff member's right elbow.

• Brand Name: CARLO COMFORT GP L
• Type of Device: MECHANICAL LIFT
• Manufacturer (Section D): BEKA HOSPITEC; DE 3 5582
• MDR Report Key: 3610237
• MDR Text Key: 4088488
• Report Number: MW5034178
• Device Sequence Number: 1
• Product Code: FSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 925001000
• Device Catalogue Number: 925001000
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 98 YR
• Patient Weight: 46