MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. FIRST STEP ALL IN ONE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 227540-R

Device Problems Deflation Problem (1149); Use of Device Problem (1670)

Patient Problem Fall (1848)

Event Date 11/20/2023

Event Type  malfunction  

Event Description

Arjo became aware that the patient fell from the first step all in one mattress installed on non-arjo bed frame (unknown bed model).The patient did not sustain any injury.The arjo service technician was informed that the bed¿s side rails were not in raised position.The customer reported also that the tube disconnected spontaneously causing mattress deflation.The involved mattress was swapped out.

Manufacturer Narrative

The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Manufacturer Narrative

The customer reported that the patient fell from mattress.The patient did not sustain any injury.The customer also alleged that the tube disconnected spontaneously causing the first step all in one mattress deflation.The arjo service technician, who attended the customer¿s facility was informed that the first step all in one mattress turning feature was active when the patient fell out of bed.Moreover, arjo product was installed on non-arjo bed frame and the bed¿s side rails were not in raised position.The turning feature provides a continuous lateral turning of patients on the air surface to a turn angle of approximately 20°.The first step all in one instruction for use (ifu p/n 227688-ah rev a 12/12) states ¿prior to engaging turn feature, ensure that bed frame has side rails and that all side rails are fully engaged in their full upright and locked position.¿ moreover, ifu warns ¿non-use of side rails can result in serious injury or death due to the potential patient falls¿ and ¿to minimize the risk of falls or injury the bed should always be in the lowest possible position when the patient is unattended¿.Based on the gathered evidence, the resident¿s fall was a result of not following the ifu.The arjo also became aware that the tube disconnected spontaneously causing the mattress deflation.The arjo employee examined the system and reported that he could not disengage the hose with his hand.No mattress faults were found.Therefore the alleged tube disconnection was not related to the patient fall.The device was swapped out at the customer's request.In summary, the first step all in one mattress played a role during this event as it was used by the patient.No arjo product malfunction was found.The patient fell from the mattress when the turning feature was on and the side rails were not in raised position.The ifu recommendations to use side rails while turning feature is active, were not followed.The complaint was assessed as reportable due to allegation of the patient¿s fall.The patient did not sustain any injury.

Event Description

Arjo became aware that the patient fell from the first step all in one mattress.The patient did not sustain any injury.The customer reported also that the tube disconnected spontaneously causing mattress deflation.The arjo service technician was informed that the mattress was installed on non-arjo bed frame (unknown bed model) and the bed¿s side rails were not in raised position.The involved mattress was swapped out.

• Brand Name: FIRST STEP ALL IN ONE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18354331
• MDR Text Key: 331317062
• Report Number: 3005619970-2023-00030
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 227540-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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