MAUDE Adverse Event Report: GETINGE (SUZHOU) CO., LTD. NIMBUS 4; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 649STD

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Power Problem (3010)

Patient Problem Pressure Sores (2326)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon the investigation conclusions.

Event Description

On (b)(6) 2016 arjohuntleigh received an information from a patient's wife requesting the service on nimbus 4 system, indicating that her husband experienced the feeling of touching the bed frame through the mattress and his pressure sores have worsened due to the system malfunction.The report was supported by photographic evidence of the outcome for patient - worsened pressure sores were assessed to be at stage 2 (minor serious injury).Mattress and pump involved in the event were tested on (b)(6) 2016 - no malfunctions were found, no spare parts were used to repair the system.Further examination revealed three notifications on the pump read with the software, regarding power failures.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information received, an incident which occurred with the involvement nimbus 4 system.Patient's wife indicated that her husband experienced the feeling of touching the bed frame through the mattress and his pressure sores have worsened due to the system malfunction.The system was suspected to have caused a low pressure.The report was supported by photographic evidence of the outcome for patient - worsened pressure sores were assessed to be at stage 2 (minor injury).When reviewing similar reportable events, we have found one other case presenting a similar scenario - ignored alarm which triggered a pressure sore for patient.The occurrence rate observed for this failure mode is currently considered to be low.Following the information gathered, it was possible to indicate the most likely scenario of the reported event.It was reported that the patient felt a bed through the mattress during the therapy which indicates a low pressure condition occurred in the system.A low pressure is usually a result of air leakage within the pump or mattress assembly or an insufficient air supply.The system was evaluated by arjohuntleigh representative who did not discover any source of system leakage.Mattress and pump were tested as a system and performed up to their specifications.During arjohuntleigh evaluation the pump was examined with the use of software diagnostic equipment which revealed errors noted by the pump during use - the unit has registered three errors related to a power supply problem, probably a disruption of the current flow.Arjohuntleigh find it most likely that the power cable has been disconnected during the therapy.Designed alarms, including a power fail alarm, were confirmed to be fully functional.The power fail alarm is powered by a rechargeable battery.The duration of the alarm will depend on the level of charge in the battery.The battery may have become discharged or reached the end of its life.The instruction for use ( 649933_02) therefore recommends to test the alarm before the pump is used.The power indicator will flash when a mains power failure has been detected.The alarm will continue until the mains power is resumed or the run/standby button is pressed and hold.A standard procedure for testing the power fail alarm covers several steps, including: connecting the pump to the mains supply, pressing run/standby button to put the pump into run mode.Removing the mains power at the wall socket without putting the pump into standby first, the power fail operates within 10 seconds - red alarm triangle flashes, the power indicator flashes, an audible warning sounds.At this point a potential battery fault is supposed to be detected.Taking into consideration that the system was serviced one month before the incident and was in a continuous use with the patient, it is unlikely that the charge level in the battery was too low.It appears most likely that the power fail alarm was launched during the therapy but was ignored.Despite a fully functional designed mitigation factor (a power fail alarm) which was alerting the caregiver about a problem with nimbus system, no immediate action was taken.The reaction of a caregiver did not prevent pressure sores from worsening.It appears most likely that the patient was not regularly monitored (according to recommendation included in the ifu) which contributed to the potential risk of a hazardous situation.Nimbus 4 system is indicated for the prevention and/or management of all categories of pressure ulcers when combined with an individualized, comprehensive pressure ulcer protocol, including repositioning, nutritional support, skin care.Selection should be based upon a holistic assessment of the patient's individual care needs.The system represents only one aspect of pressure ulcer management protocol - all other aspects of care should be considered by the prescribing clinician.[instruction for use, 649933en_02] the possible sequence of events presented above seems to be the most probable and in line with the event description.The root cause of the reported event is considered to be use error- the malfunction of the system was not noticed in a timely manner, despite a fully functional designed mitigation factor.It has been established that the nimbus system was being used for a patient therapy at the time of the event but has not malfunctioned (did perform up to specification), however its use error has contributed to the outcome of the event.

• Brand Name: NIMBUS 4
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer (Section G): GETINGE (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu, 21502 4; CH 215024
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 6138858
• MDR Text Key: 61315687
• Report Number: 3005619970-2016-00024
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2016,11/02/2016

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
• Device Operator: Other
• Device Model Number: 649STD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2016
• Distributor Facility Aware Date: 11/02/2016
• Device Age: 28 MO
• Event Location: Home
• Date Report to Manufacturer: 12/30/2016
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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