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

Model Number 649STD

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pressure Sores (2326)

Event Date 10/03/2016

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 indicating that her husband has developed pressure sore (stage 1) due to the system malfunction which occurred on (b)(6) 2016.The repair of the system was performed on (b)(6) and included the replacement of pump components - silencer bag and valve rotor - which were cracked and resulted in air leakage and a low pressure condition.During an initial request of the customer to repair the system there was no indication of any adverse patient outcome.Pressure sore was a result of an ignored pump alarm - occurred during the night.Patient's wife did not notice that the pump was alarming due to low pressure which consequently resulted in a development of a pressure sore stage 1.This scenario is in line with the records of a service repair performed after the incident- no component responsible for alarming was replaced, it may be assumed that the alarm was functional.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information received, an incident which occurred with the involvement of nimbus 4 system.Patient's wife indicated that her husband has developed pressure sore (stage 1) due to the system malfunction which occurred on (b)(6) 2016.The repair of the system was performed on 11th october and included the replacement of pump components - silencer bag and valve rotor - which were cracked and resulted in air leakage and a low pressure condition.During an initial request of the customer to repair the system (oct 2016) there was no indication from the customer regarding any outcomes to the patient.When reviewing similar reportable events, we have found no other cases presenting a similar scenario - ignored low pressure 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.The patient was laying on a flat mattress which clearly suggests a low pressure condition occurred in the system.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 the arjohuntleigh representative who has indicated the reason for air leakage.The repair of the system performed on 11th october 2016 included the replacement of two internal components of the pump - silencer bag and valve rotor.Observed malfunctions resulted in air leakage and a low pressure condition.Worth to mention is the fact that there was no replacement of any component which would be responsible for alarm functionality.It was initially assumed during the service (and confirmed along with the information about an incident) that the low pressure alarm was working properly.Patient's wife did not notice the alarm given by pump (as the event happened during night).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].Despite a fully functional designed mitigation factor (a low pressure 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 from a development of pressure sore.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.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.Arjohuntleigh suggests to remind the staff involved of the device labeling, with a special attention paid towards patient monitoring procedure and also in terms of a necessity to timely inform the manufacturer about potentially hazardous situation which occurred with the involvement of arjohuntleigh devices.This is to be communicated to the customer.It has been established that the nimbus 4 system was being used for a patient therapy at the time of the event and has malfunctioned (did not perform up to specification), however, the use error as described above, 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: 6138260
• MDR Text Key: 61315790
• Report Number: 3005619970-2016-00023
• 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: 12/22/2016,11/02/2016

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: 12/22/2016
• Distributor Facility Aware Date: 11/02/2016
• Device Age: 28 MO
• Event Location: Home
• Date Report to Manufacturer: 12/22/2016
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2016
• 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