MAUDE Adverse Event Report: ARJO DOMINICAN REPUBLIC SLINGS, CLIP; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number MAA2000M-L

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon investigation conclsuoon.

Event Description

It was reported that during patient transffer , the sling was broken, no injury was sustained.

Manufacturer Narrative

The arjo was informed about the event involving the maxi move floor lift (serial number (b)(6) and model no kmcsun) and clip sling.It was reported that during the final phase of a patient transfer (during patient lowering), the sling clip broke.No injury was reported.The sling was returned to the manufacturer for further inspection.A visual inspection of the broken clip was performed and no manufacturing defects that could contribute to the clip damage were observed.The investigated issue is a singular occurrence.The instruction for use for clip sling (04.Sc.00-int-1-a) contains information about inspection before every use: "check all parts of the sling.If any part is missing or damaged - do not use the sling.Check for: fraying, loose stitching, tears, fabric holes, soiled fabric, damaged clips, unreadable or damaged label." following information provided by the facility staff, the sling was inspected before use and no issue was found.To conclude, the system - clip sling and the lift were used for the patient¿s transfer and in that way contributed to the alleged event.The sling clip broke - and from that perspective, the system did not meet the manufacturer¿s specifications.The complaint was decided to be reported to the competent authorities due to the fact that sling clip broke during transfer.

• Brand Name: SLINGS, CLIP
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJO DOMINICAN REPUBLIC; building 9 piisa industrial pa km18 1/2 antigua carretera s; itabo 10903 ; DR 10903
• Manufacturer (Section G): ARJO DOMINICAN REPUBLIC; building 9 piisa industrial pa km18 1/2 antigua carretera s; itabo 10903 ; DR 10903
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18422953
• MDR Text Key: 331667094
• Report Number: 3012292104-2023-00009
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MAA2000M-L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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