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

Device Problems Disconnection (1171); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 07/04/2014

Event Type  malfunction  

Event Description

"hired nimbus 3 mattress from (b)(4) was reported not working on further investigation, there was evidence that the live and earth cables were not connected within the device leaving a potential to cause harm.The device was delivered out of hours and the sticker for the next pat test and inspection is (b)(6) 2015.The cables had not been pulled out and were not long enough to have ever been securely fitted within the correct connector.".

Manufacturer Narrative

(b)(4).The product involved in the incident is nimbus pump, serial number (b)(4), which was manufactured at december 21st 2004 and was nearly 10 years old at the time of incident.The device is part of the (b)(4).The product was installed at the hospital (b)(6) 2014 and the event occurred at (b)(6) 2014.Before being sent into service as rental device with this customer, the device went through our testing procedure and passed all tests ((b)(4) 2014).Moreover the p.A.T.Test was performed with no deviations noticed.We have been informed that the rental nimbus 3 pump was reported "not working and on further investigation there was evidence that the live and earth cables were not connected within the device leaving a potential to cause harm.The device was returned for a further evaluation by a (b)(4) technical support engineer.The initial visual inspection on the pump enables us to confirm that the mains power cable had been caught, which resulted in partial trapping the cable insulation.After removal of the rear casing of the pump and inspection of entrance and connection of mains power cable: it turned out that the wires that were disconnected from the terminal block were earth and neutral wire, not as claimed by customer earth and live wire.The securing clamp was not fastened onto the outer sheath of the mains power cable.Based on all information collected to date, the root cause for the cable detaching from the terminal block was a combination of a very strong cable pull (which could be confirmed by the trace of pinching on the cable outer insulation), and inadequate protection of wires from detachment (cable clamp not secured during conducted pump service, in the way that it is advised in product service manual).Review of our post market surveillance data revealed that there were no previous complaints in which wires of the power cable were disconnected and the allegation that this scenario could cause a potential harm to the user.We take all issues of this nature seriously and will continue to monitor any future trends that may arise from the use of our products, however, based on the information provided, in this single occurrence the device failed to meet its specifications as it suffered a malfunction due to combination of use error and refurbishment/installation error, however, there was no patient involvement or injuries as a result.(b)(4).

• 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: 4114193
• MDR Text Key: 4941044
• Report Number: 3005619970-2014-00007
• 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: Unknown
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/18/2014,07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2014
• Distributor Facility Aware Date: 07/22/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/20/2014
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2004
• 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