FDA Adverse Event
Malfunction
Summary report: N
GUARDIAN
MDR report key: 965064
·
Received July 6, 2007
Report
- Report Number
- 3003781173-2006-00004
- Event Type
- Malfunction
- Date Received
- July 6, 2007
- Date of Event
- June 13, 2006
- Report Date
- July 3, 2006
- Manufacturer
- ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD.
- Product Code
- ITJ
- Removal / Correction Number
- 3003781173-7/03/06-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THIS EVENT WAS REPORTED TO SUNRISE CUSTOMER SERVICE VIA PHONE CALL FROM THE REPORTER ON 6/20/06. SUNRISE MEDICAL SUBSEQUENTLY PROVIDED MDR #1034630-2006-0026 TO US AGENT FOR ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD., ON 06/27/06. REPORTER CLAIMS THE CENTER PORTION OF THE CUSTOMER'S (WHEEL?) CRACKED. THE UNIT HAS NOT BEEN REC'D FOR EVAL BY SUNRISE MEDICAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDIAN | 8 HOLE FOOTPIECE SET 5" WHEEL | ITJ | ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD. | 07722-8 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |