Interacoustics OtoRead - Return Report

OtoRead Screener Page 54
Return Report
– Form 001
Opr.
dato:
2003-02-24
af:
EC
Rev.
dato:
2003-02-24
af:
EC
Rev. nr.:
1
Company:
Address:
Phone:
Fax:
Contact person:
Date :
Following item is reported to be:
returned to INTERACOUSTICS for: repair, exchange, other:
defective as described below with request of assistance
repaired locally as described below
showing general problems as described below
Item:
Type:
Quantity:
Serial No.:
Supplied by:
Included parts:
Description of problem or the performed local repair:
Returned according to agreement with:
Interacoustics, Other :
Date :
Person :
The above mentioned item is reported to be dangerous to patient or user
1
In order to ensure instant and effective treatment of returned goods, it is important that this
form is filled in and placed together with the item.
Please note that the goods must be carefully packed, preferably in original packing, in order to
avoid damage during transport. (Packing material may be ordered from Interacoustics.
1
EC Medical Device Directive rules require immediate report to be sent, if the device by malfunction
deterioration of performance or characteristics and/or by inadequacy in labelling or instructions for use, has
caused or could have caused death or serious deterioration of health to patient or user.
Address
DGS Diagnostics Sp. Z o.o.
Ul. Wiosenna 5
72-006 Mierzyn, Szezecin
Polska
Phone
(+48) 91 441 7700
Web
info@interacoustics.com