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

Model Number 625301

Device Problems Break (1069); Component Falling (1105)

Patient Problems Bruise/Contusion (1754); No Patient Involvement (2645)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

Arjohuntleigh have been informed that whilst the breeze pump was being hung on the end of the bed, the hanging bracket broke and the pump landed on the nurse foot.The overall outcome was foot swollen and bruised.The pump and bracket were removed from the pump and return to the depot.Mfr - 1000381138-2014-00007.

• Brand Name: BREEZE
• 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: 3913237
• MDR Text Key: 20857079
• Report Number: 1419652-2014-00127
• Device Sequence Number: 1
• Product Code: FNM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2014,04/11/2014

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
• Device Model Number: 625301
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2014
• Distributor Facility Aware Date: 04/11/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other