MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MINSTREL (INCL. MINERVA); NONE

Model Number HMA0002

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2014

Event Type  malfunction  

Event Description

It was reported by the company representative: "spreader bar detached from scale during transfer from wheel chair to the bed.Resident dropped to the bed and the spreader bar fell on the chest." no injuries are detected.Ref mfr #3007420694-2014-00009.

• Brand Name: MINSTREL (INCL. MINERVA)
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• MDR Report Key: 3659319
• MDR Text Key: 4196139
• Report Number: 1419652-2014-00035
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/07/2014,01/09/2014

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
• Device Model Number: HMA0002
• 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: 01/09/2014
• 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