MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MINUET

Device Problems Kinked (1339); Device Maintenance Issue (1379); Unintended System Motion (1430)

Patient Problems Bruise/Contusion (1754); Contusion (1787)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

It has been indicated by the customer that: "maintenance man was looking at the backrest of a minuet bed that looked bent.He then put his hand on the bed fabrication to have a look and the backrest unexpectedly lowered onto his hand causing bruising." ref mfr #3007420694-2014-00008.

• Brand Name: MINUET
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• 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: 3659328
• MDR Text Key: 4196654
• Report Number: 1419652-2014-00034
• Device Sequence Number: 1
• Product Code: LLI
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• 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: 02/07/2014
• Distributor Facility Aware Date: 01/08/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other