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

Model Number 649STD

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Burn(s) (1757)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjohuntleigh was informed about an event which occurred with the involvement of nimbus 4 pump.It was reported that the system was being installed on patient's bed.When the pump cable was plugged into the socket, a loud bang and spark occurred - the plug blown the circuit.As a result, the person who made an installation received a harm to the right hand index finger - a burn.The severity of received injury remained unknown, no information regarding further treatment of the injured was provided to date.No injuries to the patient sustained.

Manufacturer Narrative

(b)(4) is in the process of data analysis.Additional information will be submitted following the conclusion of the investigation.

Manufacturer Narrative

An investigation was carried out into this complaint.Arjohuntleigh has received an information that the facility staff experienced a harm of the index finger when plugging the pump in the socket - a short circuit, accompanied by the loud bang and sparks occurred- the plug blown the circuit.As a result, the person who made an installation received a harm to the right hand index finger - a burn.The severity of received injury remained unknown, no information regarding further treatment of the injured was obtained to date.No injuries to the patient sustained.When reviewing similar reportable events, we have found a number of other cases presenting scenarios of hazardous situations related to electrical components.However, the occurrence rate observed for this failure mode is currently considered to be very low.The involved system was inspected by arjohuntleigh representatives.Based on the provided photographic evidence following device evaluation, minor signs of smoking were visible on one of the plug pins.The pins were bent.Plug cover was intact, with no signs of melting.A general condition of the suspected power cable was assessed as poor - internal wires of the cable were twisted.The power cable was identified as a source of the short circuit.Even though the condition of the cable was assessed as 'poor' at the time of device evaluation after the event (bent plug pins, internal wires twisted), the attempt to make the installation of the product was made.Twisted internal wires and bent plug pins resulted in a disturbed flow of electrical current which consequently led to the short circuit when plugged.The installation of the pump with a worn power cable resulted in a hazardous situation with an involvement of the facility staff.As the mains cable is a critical component of pump assembly, it is very important to consider and follow all the safety warnings and general maintenance rules provided in instruction for use and service manual.According to the instruction for use (649933_01): 'check all electrical connections and power cord for signs of excessive wear.' ( routine maintenance, 8) 'make sure that the mains power cable and tubeset or air hoses are positioned to avoid causing a trip or other hazard, and are clear of moving bed mechanisms or other possible entrapment areas.Where cable management flaps are provided along the sides of the mattress, these should be used to cover the mains power cable.Disconnect the pump from the mains power socket before cleaning and inspecting.'(safety warnings) in summary, basing on all the facts gathered to date, the scenario of a short circuit caused by the attempt to install the product with a worn power cable is the most probable and in line with the event description.It is recommended to handle and maintain nimbus pump with caution and care, making sure that all electrical connections are checked for signs of excessive wear before use.The facility was informed about the device labelling with special attention paid towards a careful device handling, especially its electrical parts, including the power cable.It was possible to establish that nimbus pump was not being used for a patient therapy at the time of the event.The device was found to have malfunctioned (not performing to specification) which contributed to the outcome of the incident.

• 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
• MDR Report Key: 7076849
• MDR Text Key: 94647845
• Report Number: 3005619970-2017-00029
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2018

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 Caregivers
• Device Model Number: 649STD
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2018
• Distributor Facility Aware Date: 11/03/2017
• Device Age: 33 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2018
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 11/03/2017; 11/03/2017
• Supplement Dates FDA Received: 12/22/2017; 01/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other