MAUDE Adverse Event Report: GETINGE (SUZHOU) CO. LTD. NIMBUS 3/ DFS3

Device Problem Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

It was reported by the customer that 'bed made a loud bang noise and blue flash when patient got on.' there were no reported injuries.

Manufacturer Narrative

(b)(4)).This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to use error the device did not perform as intended.The product involved in the incident is nimbus 3 mattress system; the device was manufactured in 27 february 2002.The pump is a part of an arjohuntleigh rental fleet and is under regular service contract.The last maintenance of the pump was performed on (b)(6) 2014 (four days prior to the incident - (b)(6) 2014).Impref#1419652-2014-00188.There was an electrical test made and the pump passed electrical safety evaluation.The due date of next test was dated on (b)(6) 2015.We have been informed by the customer that the 'bed mad a loud bang noise and blue flash when patient got on'.Upon the additional information being provided we have been able to confirm the following: the patient who was mobile was getting back onto the contoura c480 bed on which the nimbus 3 mattress was installed.As the patient climbed on the bed there was a loud bang and blue flash was visible.Inspection of the bed revealed the device was in good condition and working in accordance to specification.The nimbus 3 system was also evaluated and on inspection the mains cable was found damaged and the technician could see a flash damage.The pump was marked appropriately and taken out of use.The operating manual as well as preventative maintenance schedule was available to the user.From the information collected to date the root cause of the mains cable insulation integrity breakage, causing exposed live wires and as a result, a blue flash - indicating a risk of electrical shock.It appears this was caused inadequate controls by the user for safeguarding the mains cable during use and entrapment by moving bed mechanisms: the positon of the damage to the cable is consistent with being run over by the foot end castors of the bed.The mains cable is a fundamental part of the system and as such should be regarded as a critical component which should be regularly inspected for any signs of excessive wear or damage.It appears a correct evaluation of the situation which would have come from following the procedures in the device labeling would have additionally precluded the event from occurring.In summary, the device was being used at the time of the event for patient treatment, it failed to meet its specifications as it suffered a malfunction due to a use error, however, there was no patient involvement or injuries as a result.We take all issues of this nature seriously and will continue to monitory any future trends that may arise from the use of our products, however, based on the information provided, we believe the contributing factor in the power cable damage was the failure of appropriate management of the power cable as instructed by the device labeling.

• Brand Name: NIMBUS 3/ DFS3
• Manufacturer (Section D): GETINGE (SUZHOU) CO. LTD.; no. 158 fangzhou road; sip, suzhou, jiangsu; suzhou 2150 24; CH 215024
• Manufacturer (Section G): GETINGE (SUZHOU) CO. LTD.; no. 158 fangzhou road; sip, suzhou, jiangsu,; suzhou 2150 24; CH 215024
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4001958
• MDR Text Key: 4954926
• Report Number: 3005619970-2014-00006
• 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: Consumer,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/27/2014

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2014
• Distributor Facility Aware Date: 06/27/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2014
• Initial Date Manufacturer Received: 06/27/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2002
• 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 Weight: 95