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

Model Number HMA0007-UK

Device Problem Device Tipped Over (2589)

Patient Problem No Information (3190)

Event Date 04/28/2014

Event Type  Other  

Event Description

It was initially reported by the company representative: hoist tipped over whilst in use and the staff at time reported that spreader bar was stiff and difficult to use.Nominated investigator to attend site to complete incident description form (idf) and take supporting photos.Ref mfr# 3007420694-2014-00062.

• Brand Name: MINSTREL (INCL. MINERVA)
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGHT POLSKA SP. ZO.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: 3888128
• MDR Text Key: 4539779
• Report Number: 1419652-2014-00141
• Device Sequence Number: 1
• Product Code: FNG
• 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: 05/29/2014,04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: HMA0007-UK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2014
• Distributor Facility Aware Date: 04/29/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other