MAUDE Adverse Event Report: JOERNS HEALTHCARE HOYER HPL700; PATIENT LIFT

Model Number HPL700WSC

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 01/16/2018

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, "facility associate mentioned the original kingpin/cradle had broken and the cradle fell onto a resident while they were lifting them out of bed.They added there were no serious injuries as the resident was still in bed but the cradle fell onto the resident." upon speaking to the facility, they stated "that the staff was lifting the patient out of the recliner chair to put them to bed.The cradle broke and patient landed in the recliner chair.The cradle fell onto the patient." (b)(4) were entered into our system to have the lift returned to joerns for investigation.As of this writing, the lift has not been returned.

• Brand Name: HOYER HPL700
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7232545
• MDR Text Key: 98716092
• Report Number: 3009402404-2018-00005
• Device Sequence Number: 1
• Product Code: FSA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/31/2018

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: Health Professional
• Device Model Number: HPL700WSC
• Device Catalogue Number: HPL700WSC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Weight: 118