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

Model Number 161AA8A1A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It has been indicated by the customer that one of the safety side dropped out of the guide channel for rails to the floor.Ref mfr report: 3007420694-2014-00057.

• Brand Name: MINUET
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• MDR Report Key: 3832497
• MDR Text Key: 15118296
• Report Number: 1419652-2014-00132
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 161AA8A1A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2014
• Distributor Facility Aware Date: 04/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other