MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. NIMBUS 3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Deflation Problem (1149)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the manufacturer's investigation.

Event Description

Arjo was informed by (b)(6) about a patient death.The patient passed away on (b)(6) 2016, at (b)(6) hospital in (b)(6).The report stated that the mattress became deflated when the power cable into the pump was dislodged.

Manufacturer Narrative

Despite extensive enquiry no record of arjo being notified of this incident can be found.There is a suggestion that the equipment may have come from cornwall equipment loan store.Though there is insufficient detail to identify equipment.As per cornwall equipment loan store manager, nimbus 3 equipment was from loan stock.No record (from 2016) indicating that there was a failure or there was any injury.Additional information will be provided upon conclusion of the manufacturer's investigation.

Manufacturer Narrative

We are reviewing the gathered information.When the investigation conclusion is available we will provide a follow-up report.

Manufacturer Narrative

An investigation was carried out for this complaint with the following conclusions: due to the lack of information about the exact circumstances of this event, arjo was left to review the information received from the medicines & healthcare products regulatory agency (mhra) per our best efforts and compare it to our product knowledge.The reported patient death concerns a female patient with a generally compromised medical state including a number of health issues such as morbid obesity and type ii diabetes mellitus, a systemic sepsis (arjo does not know when the patient developed sepsis), infected sacral decubitus ulcer (operated), and frailty which caused the patient death.Additionally, it was reported that an unsuccessful transfer into a community hospital contributed to the patient outcome.A coroner reported that in the previous days to the death, while treating patient's preexistent sacral pressure ulcer with a nimbus 3 mattress, the mattress was found deflated due to the power cable being dislodged.It was reported that patient developed a sacral ulcer in early (b)(6) 2016.The coroner expressed concern that the pump might not have alarmed to alert users to the problem.The nimbus 3 system was not evaluated by arjo since serial number was not revealed and the information about the event was provided to arjo 2,5 years later.Arjo did receive information from cornwall equipment loan store (bodmin) who owned the involved system that they had no records of failure or an injury.In case a power cord is dislodged, the system will detect an alarm condition and both the yellow indicator light will illuminate and an audible warning alarm will sound.The nimbus 3 system incorporates alarms such as a power fail alarm or a low-pressure alarm.Also, in the case of a power cord being dislodged the mattress will not lose air immediately but rather the air pressure will gradually escape from the mattress.It is unknown how long or if the patient was left on the deflated mattress and why the alarm condition was not addressed.While consulting about this event with the responsible manufacturing site for nimbus 3 mattress, two hypothesis were considered in respect to alleged faulty alarm: there was no power in the battery which powered the alarm.During a power failure condition, the light indicator and an audible alarm are powered by a backup battery.If the battery is fully charged, the alarm will last for over 20 minutes.The alarm was not noticed by the user and the battery power was eventually exhausted.It is unknown whether user noticed the alarm or the alarm was recognized by user but "alarm mute" button was pressed.Cornwall equipment loan store (bodmin) did no find records of failure of the system; therefore, it can be assumed that the battery did not fail, the alarm was working as intended.Prior to being placed on the nimbus 3 mattress, the patient was already in a compromised medical condition, which included a number of health issues: morbid obesity, type ii diabetes mellitus, a fall which further reduced her mobility and a sacral pressure ulcer.All of the mentioned medical conditions require individual care and assessment.It is worth remembering that, the nimbus 3 system is indicated for the prevention and management of pressure ulcers while being combined with individualized monitoring, repositioning and wound care program.Taking into account the patient's overall medical condition and circumstances surrounding the event (delay in hospital treatment), it was concluded that patient's death was most likely a result of serious comorbidities and delay in treatment.In conclusion, based on the provided information, the mattress was used by the patient in the previous days to the death.The nimbus 3 system was not evaluated by arjo since the serial number was not revealed and the information about the event was provided to arjo 2,5 years later.The patient's death was most likely a result of serious comorbidities and delay in transfer, therefore, arjo could not find a correlation between the reported failure and the patient's death.Therefore, the root cause of this incident remains unknown.

• Brand Name: NIMBUS 3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, 21502 4; CH 215024
• MDR Report Key: 8743270
• MDR Text Key: 149478439
• Report Number: 3005619970-2019-00009
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2019
• Distributor Facility Aware Date: 06/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 06/18/2019; 06/18/2019; 06/18/2019
• Supplement Dates FDA Received: 07/26/2019; 08/23/2019; 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death