MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB ALPHA RELIEF

Model Number ALR04

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2014

Event Type  malfunction  

Event Description

Customer reports to its personnel to be cautious due to the fact that there seems to be problems between the junction of the cable and plug of the alpha relief power cord.An incident happened on the (b)(6), where a nurse received an electrical shock on the cable of the mattress pump.Ref# mfr 1000381138-2014-00005.

• Brand Name: ALPHA RELIEF
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall; houghton regis, bedfordshire LU5 5XF; UK LU5 5XF
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3799195
• MDR Text Key: 4366512
• Report Number: 1419652-2014-00117
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALR04
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2014
• Distributor Facility Aware Date: 03/31/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other