MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z.O.O SLINGS, CLIP

Model Number HOY-STATURE

Device Problems Detachment Of Device Component (1104); Off-Label Use (1494); Inadequate or Insufficient Training (1643)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 12/17/2013

Event Type  malfunction  

Event Description

Arjohuntleigh received a complaint where it was indicated that during the resident transfer one of the sling clips came off the lift, dropping the patient.No injuries were reported as a consequence of the event.The model number of the sling involved in the incident was not provided but in accordance to photos attached to the complaint we can determine that this is a sling model: maa2000m-m (unpadded clip sling, medium size).The serial number was not provided and there is no possibility to read the serial number as the label of the sling is unreadable as it was shown on the photos.The lift involved in the incident was found to be no arjohuntleigh lift, but a competitor product that has not been validated by arjohuntleigh (hoyer stature).It was indicated in description of the event that "the arjohuntleigh sling does not fit the cradle properly.The sling can be placed on the cradle at the pins however the sling clip does not securely clip into place on the cradle." ref mfr # 3007420694-2014-00016.

• Brand Name: SLINGS, CLIP
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z.O.O; ul ks piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3674870
• MDR Text Key: 15267622
• Report Number: 1419652-2014-00049
• Device Sequence Number: 1
• Product Code: IKX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2014,01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HOY-STATURE
• 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: 02/20/2014
• Distributor Facility Aware Date: 01/21/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other