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Adverse Event Report

DISTRIBUTED PRODUCT VARIOUS INVACARE PATIENT SCALE 880.2720   back to search results
Model Number 9833
Event Date 04/25/2002
Event Type  Malfunction  
Manufacturer Narrative

Two scales were returned. Both were observed to be missing the small set screw with passes through the hooked end that attaches over the bolt in the lift. The purpose of the setscrew is to prevent the assembly, when not under load, from being bumped and becoming unhooked from the lift body and falling on the pt. When loaded, as when moving a pt, it is not possible for the unit to lift up and unhook from cross bolt. The absence of the screw does not reduce the lifting performance of the lilft. No correlation between missing screw and complaint. Invacare does not instal this screw. The screw ships with the product for installation by the facility when the scale is installed. No malfunction occurred. This scale is not part of a field action currently under way.

 
Event Description

The facility alleges the lift lost a screw and consequently dropped the pt. No serious injury alleged or reported.

 
Manufacturer Narrative

Product will not be returned to mfr for eval. Pt was not severely injured. While the exact malfunction is unk, a field action of this product has been initiated.

 
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Brand NameINVACARE PATIENT SCALE
Type of Device880.2720
Baseline Brand NameINVACARE PATIENT SCALE
Baseline Generic Name880.2720
Baseline Model Number9833
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DISTRIBUTED PRODUCT VARIOUS
*
Manufacturer (Section D)
DISTRIBUTED PRODUCT VARIOUS
*
Manufacturer Contact
ron clines
one invacare way
elyria , OH 44036
(440) 326 -3115
Device Event Key385882
MDR Report Key396836
Event Key374944
Report Number1525712-2002-00046
Device Sequence Number1
Product CodeFRW
Report Source Manufacturer
Source Type User facility
Reporter Occupation NO INFORMATION
Type of Report Initial,Followup
Report Date 05/02/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL Number9833
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/30/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2002
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on December 31, 2008

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