MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AII

Device Problems Device Maintenance Issue (1379); Battery Problem (2885); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Eye Injury (1845)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

It was initially reported by company representative that during repair of sound and vision remote control, the top of the battery blew off as the service technician was trying to remove the top cover/cap.The force of pulling the top caused the battery to split forcing the contents into the atmosphere into the engineer and another fitter nearby.Injury was reported as a battery fluid in right eye.Injured was taken to local accident and emergency department where a treatment was given - eyes washed out, and the engineer had to report to an eye clinic.Part examination described in incident description form (idf) showed that the battery had suffered damage due to water ingress.The handset had been broken open to gain access to the battery.Information included in idf confirmed also that service technicians were aware that the handset is a consumable item and not to be repaired.Additional information regarding this incident were provided that informs about possible cause of this failure: "the incident occurred outside of normal use, however it is possible that the handset could be dropped the handset casing to split, the glass seal of the battery to break leading to leakage and the generation of irritating/corrosive gases resulting in possible injuries to others.".

Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjo hospital equipment ab on behalf of the importer (b)(4).When reviewing similar reportable events for system 2000 we haven't found any other similar cases - injury from the battery during repair of sound and vision remote.We have been able to establish that there is no complaint trend concerning these kind of events.Please note that arjohuntleigh manufactured over (b)(4) system 2000 baths to date the faulty part was inspected by an arjohuntleigh representative and found to be out of the specification - remote not working and possible water ingress.The device was being repaired by service technicians and in that way contributed to the event.From received information pressurised battery liquid got into engineer's eyes.Injured was taken to a local accident and emergency department where a treatment was given eye washed out.Ifu's technical requirement section informs also that sound and vision hand control in accordance to ip class ((b)(4)) has been classified as "ip x7".Ip x7 means that the parts should be able to be 1 minute under water for 30 min without water penetration.The remote control is welded tight and is not possible to open without destroying the casing.Ip x7 class has been confirmed in test report (b)(4).Sound and vision remote control is a consumable part and should not be tempered with or opened.Received information showed that service technicians were aware of it, but opened it to replace a battery anyway.Information about service of the device can be found in maintenance and repair manual (09 april 07/3gb from june 2009, the earliest available document that includes sound and vision function, due to no serial number of involved device was provided.) manual warns: " the following actions must be carried out by qualified personnel, using correct tools and knowledge or procedures.Failure to meet these requirements could result in personal injuries and/or unsafe product." it provides also information about replacement procedure for sound and vision, however it doesn't include replacement of remote's battery.Maintenance and repair manual includes similar troubleshooting as instructions for use.In accordance to it: "problem: no function; remote control led is off when button is pressed.Cause: remote control defect.Action: check led on remote control: if not flashing when operated.Replace remote control".From above we can conclude that this problem was caused by a combination of: user error - damaged part as indicated: possible drop and fail into the water.Service error - incorrect service of faulty part: remote should not be opened and battery should not be replaced.The received information and out evaluation as described above are showing that if system 2000's warnings were followed in accordance to instruction for use and maintenance and repair manual, there would be no person at risk.Imp ref# (b)(4).

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5,; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5,; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4114197
• MDR Text Key: 4922756
• Report Number: 9611530-2014-00063
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AII
• 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: 08/20/2014
• Distributor Facility Aware Date: 07/21/2014
• Event Location: Other
• Date Report to Manufacturer: 08/20/2014
• Initial Date Manufacturer Received: 07/21/2014
• Initial Date FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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