MAUDE Adverse Event Report: ARJO DOMINICAN REPUBLIC SLINGS, CLIP; LIFT, PATIENT, NON-AC-POWERED

Model Number	MAA2040M-M-L1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Arjo was informed about an incident involving the arjo passive clip sling (model number: maa2040m-m-l1, serial number: (b)(4)) and the floor lift from the tr-care company (non arjo device).It was reported that a caregiver attempted to transfer the patient who was lying on the bed.The passive clip sling was placed under the patient.During attaching the sling to the lift, caregiver noticed that the right shoulder clip detached from the spreader bar.The caregiver reattached the clip and raised the patient above the bed when suddenly the left shoulder clip detached from the spreader bar.As a consequence, the patient fell down on the bed (approximately 20-30 cm).The fall did not result in any injuries.
Additional Manufacturer Narrative
Arjo was informed about an incident involving the arjo passive clip sling (model number: maa2040m-m-l1, serial number: (b)(4)) and the floor lift from the tr-care company (non arjo device).It was reported that a caregiver attempted to transfer the patient who was lying on the bed.The passive clip sling was placed under the patient.During attaching the sling to the lift, caregiver noticed that the right shoulder clip detached from the spreader bar.The caregiver reattached the clip and raised the patient above the bed when suddenly the left shoulder clip detached from the spreader bar.As a consequence, the patient fell down on the bed (approximately 20-30 cm).The fall did not result in any injuries.The instructions for use (ifu) for the passive clip slings (document number: 04.Sc.00-int1_6) states that: ¿the passive clip slings should be used together with arjo lift devices in accordance with the allowed combinations specified in the instruction for use.¿ the document also warns: ¿to avoid injury, always follow the allowed combinations listed in this ifu.No other combinations are allowed.¿ non-arjo device ¿ floor lift from the tr-care company involved in the incident is not listed in the sling instruction for use under combinations of devices allowed to be used with the arjo slings.To sum up, the non-arjo passive floor lift and arjo passive clip sling were used as a system for a patient transfer when the resident fell out of the device and from that perspective this system failed.As a medical device manufacturer, arjo is responsible to ensure that its medical device and its authorized accessories are safe and effective for use in accordance with the product¿s instructions for use manual.To ensure no compromise of safety, risk of liability, and to rely upon extensive product and accessory testing, performance and experience, arjo recommends the use of arjo branded slings to be utilized with arjo patient lifts in accordance with the devices¿ instructions for use manual.We decided to report this complaint to the competent authorities due to the clip detachment during use.

• Brand Name: SLINGS, CLIP
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• 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: 13598459
• Report Number: 3012292104-2022-00001
• Device Sequence Number: 1969433
• Product Code: FSA
• UDI-Device Identifier: 05056097336855
• UDI-Public: (01)05056097336855(11)210626
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: MAA2040M-M-L1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 69 KG