MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 630001

Device Problems Deflation Problem (1149); No Apparent Adverse Event (3189)

Patient Problem Pain (1994)

Event Date 11/05/2022

Event Type  malfunction  

Event Description

It was reported by the patient's family member that an auto logic mattress deflated.The patient was laying on a hard surface for several hours and experienced "extreme pain".It is unknown if any medical intervention was needed.

Manufacturer Narrative

The complaint was reported as serious injury in abundance of caution as description of extreme pain in a situation where the mattress deflates and the patient is laying on a hard surface for several hours could indicate the formation of a deep tissue injury.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Manufacturer Narrative

It was reported by the patient's family member that an auto logic mattress deflated and the audible alarm was triggered by the pump.The customer stated, that the patient was laying on a hard surface for several hours and experienced "extreme pain".Initially, the patient¿s sensation was assessed as a serious injury as ¿extreme pain¿ was thought to potentially indicate the formation of a deep tissue injury.And therefore, this complaint was deemed reportable to competent authorities.Later, arjo became aware that no serious injury occurred.The patient received the pain medication to deal with the pain and no medical intervention was needed.The arjo service technician visited the customer facility the same day.The claimed system was still in use at that time.The mattress was fully deflated and the red low-pressure indicator illuminated on the front of the pump.The auto logic system is equipped with a sophisticated alarm system that differentiates between normal operation and genuine system faults.The alarm system worked correctly on the claimed device since the red light was visible and audible alarm was sound.The red light means that there is lower pressure in the mattress.The technician performed a few resets of the pump but it did not provide any air to the mattress therefore it was replaced.There was no issue with the mattress, it remained in use and was picked-up by arjo few days later.The arjo technician and the patient¿s family observed that the patient used the 8 years old pump that was not serviced since aug 2021.According to instruction for use (630933en_1), the auto logic system should be serviced after 12 months of continuous running time, by an authorized service agent.The need of service is indicated by the illumination of the service symbol located on the front of the pump.When the service indicator is illuminated on the pump, the device will continue to function normally, but the service should be arranged.The claimed pump was a property of southern trust (no-arjo) therefore it is unknown why it was not serviced in 2022 and when and by who it was installed.When the reported faulty pump and the mattress returned to the arjo service center it was further evaluated.The evaluation of both mattress and the pump revealed visual damage to the pump (which was a screw missing) that did not affect the mechanics of the pump.The functional test on mattress and pump showed that the system was working properly and no faults were found.The system was run over the weekend with weight and also no issue was detected.Based on the results of system evaluation, the customer allegation could not be confirmed.This complaint was initially assessed as reportable due to information suggested formation of a deep tissue injury.After inspection of the system and additional information received, it was concluded that, the system did not fail.It is unknown why the customer reported a mattress deflation.Nothing indicates that an alleged mattress deflation was a result of a product failure.The reported event was deemed not meeting vigilance criteria.The alleged mattress deflation did not result in a death or a serious deterioration in state of health and is unlikely to lead to a death or serious deterioration in state of health in the future.As it was described in the instruction for use the system has a sophisticated alarm system differentiates between normal operation and genuine system faults.If an alarm situation is detected an indicator illuminates on the top and front of the pump and an audible warning sounds.The mattress type 200 (as used by the customer) has an air filled zoned sub-mattress which is always inflated, therefore the bottom section of the mattress will not be at zero pressure.Additionally, one of the key factor in patient care is a patient¿s skin care management protocol.According to instruction for use (630933en_1), ¿the auto logic systems are indicated for the prevention and/or management of all categories of pressure ulcer, when combined with an individualized, comprehensive pressure ulcer protocol: for example: repositioning, nutritional support, skin care.¿ in summary, the complaint was initially assessed as reportable due to information indicating a serious injury which, in the course of the investigation, proved to be erroneous.This system incorporates alarms which are triggered whenever the system senses an undesired condition.In this complaint, the system worked as intended since the alarm was activated.Taking all the facts into account, this complaint is deemed not reportable to competent authority.Arjo will not be reporting future complaints of this type.However, arjo will continue monitoring the complaints and report any events in which death and/or serious injury occurred that arjo device contributed to.

Event Description

It was reported by the patient's family member that an auto logic mattress deflated and the audible alarm was triggered by the pump.The customer stated, that the patient was laying on a hard surface for several hours and experienced "extreme pain".Initially, the patient¿s sensation was assessed as a serious injury as ¿extreme pain¿ was thought to potentially indicate the formation of a deep tissue injury.And therefore, this complaint was deemed reportable to competent authorities.Later, arjo became aware that no serious injury occurred.The patient received the pain medication to deal with the pain and no medical intervention was needed.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15860288
• MDR Text Key: 304282774
• Report Number: 3005619970-2022-00028
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 630001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2022
• Date Device Manufactured: 11/10/2014
• 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
• Patient Sex: Female