FDA Adverse Event
Malfunction
Summary report: N
INVACARE MEDICAL
MDR report key: 4638746
·
Received March 10, 2015
Report
- Report Number
- 3004766495-2015-00039
- Event Type
- Malfunction
- Date Received
- March 10, 2015
- Report Date
- February 16, 2015
- Manufacturer
- DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEFECTIVE PRODUCT HAS MIXED TO PRODUCTION LINE, THE DEFECTIVE PRODUCTION DIDN'T PROPERLY ISOLATED AND LABELLED. REQUEST THE LEADER OF WORKSHOP PERFORM 6S, AVOID DEFECTIVE PRODUCT MIXING TO PRODUCTION LINES AGAIN. RESPONSIBLE PERSON: (B)(4), DATE 02/15/2015. ASK THE PURCHASING DEPARTMENT TO INFORM THE RM SUPPLIER, MAKE SURE THE MATERIAL OF SCREW MEET THE REQUIREMENT. RESPONSIBLE PERSON: (B)(4), DATE: 02/15/2015.
Description of Event or Problem · 1
DEALER CALLED TO REPORT THAT TREX20RP WAS RECEIVED WITH DAMAGE TO THE PIVOT LINKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166184 | INVACARE MEDICAL | MECHANICAL (MANUAL) WHEELCHAIR | IOR | DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. | TREX20RP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |