MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MAXI TWIN; LIFT, PATIENT, NON-AC-POWERED

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon investigation conlusion.

Event Description

It was reported that during transfer when the resident was raised above the bed, the patient slip out of the sling.No injury was reported.Collecting of the information is ongoing.

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Manufacturer Narrative

The customer informed the arjo representative about an event involving a maxi twin floor lift and a sling.It was reported that a patient slipped out of the sling during transfer from a bed.No injury was reported.Upon interviewing with the customer, it was revealed that the xl size of the sling was considered too small for their resident.Subsequently, the customer ordered two straps of size xxl in an attempt to address the sizing issue.However, during testing, it became apparent that the length of the "legs" of the xxl strap was excessively large.The sling was returned to arjo to check the dimensions of the sling.The manufacturer analysis revealed that there was no disproportion found which might led to the patient's fall.The instruction for use for passive clip sling contains information that: " the right type and size of slings should be used after proper assessment of each patient/resident's size, condition and the type of lifting situation.If the patient/resident does not meet these criteria.An alternative eauipment/system shall be used." based on provided information by the customer we are unable to define the root cause of the reported patient fall.To sum up, the arjo sling was used during the patient transfer.The patient slipped out of the device and in this regard, the lift and the sling which work as a system did not meet its performance specification.The complaint was decided to be reportable due to the information that the patient fell out from the device during transfer.

• Brand Name: MAXI TWIN
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18281326
• MDR Text Key: 329894687
• Report Number: 3007420694-2023-00294
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2023
• 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): Other