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U.S. Department of Health and Human Services

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

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ARJOHUNTLEIGHT POLSKA SP. ZO.O MINSTREL (INCL. MINERVA) NONE Back to Search Results
Model Number HMA0007-UK
Device Problem Device Tipped Over
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.

 
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Brand NameMINSTREL (INCL. MINERVA)
Type of DeviceNONE
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 Key3888128
Report Number1419652-2014-00141
Device Sequence Number1
Product CodeFNG
Report Source Distributor
Reporter Occupation
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 Received05/30/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberHMA0007-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 FDA05/29/2014
Distributor Facility Aware Date04/29/2014
Device Age1 yr
Event Location Hospital
Date Report TO Manufacturer05/29/2014
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 05/30/2014 Patient Sequence Number: 1
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