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

Model Number CM-ACC06-1

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem Laceration(s) (1946)

Event Date 03/01/2011

Event Type  malfunction  

Event Description

It has been claimed that one of the screw on an optional accessory - safety side panel, has worked itself loose and a service user has injured herself on it.Reference mfr report #3007420694-2014-00023.

• 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: 3723531
• MDR Text Key: 4310388
• Report Number: 1419652-2014-00066
• 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: 03/16/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CM-ACC06-1
• 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: 03/07/2014
• Distributor Facility Aware Date: 03/16/2011
• Date Report to Manufacturer: 03/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other