FDA Adverse Event
Malfunction
Summary report: N
9XT SWINGAWAY FRAME STYLE 9153629153
MDR report key: 5110173
·
Received September 29, 2015
Report
- Report Number
- 9616091-2015-02374
- Event Type
- Malfunction
- Date Received
- September 29, 2015
- Report Date
- October 13, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL/UPDATED INFORMATION WAS ADDED TO REFLECT THE DEVICE BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULT OF THE EVALUATION WAS THAT THE ARM GUSSET WAS BROKEN OFF AT THE WELD ON THE LEFT SIDE FRAME, WHICH CONFIRMED THE ORIGINAL COMPLAINT ISSUE. HOWEVER, THE UNDERLYING CAUSE COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOR THE PATIENT, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
DEALER STATES THE REAR WELDED ARMREST BRACKET ON THE BACK OF THE LEFT FRAME HAS BROKEN ALL THE WAY OFF.
Description of Event or Problem · 1
DEALER STATES THE REAR WELDED ARMREST BRACKET ON THE BACK OF THE LEFT FRAME HAS BROKEN ALL THE WAY OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642603 | 9XT SWINGAWAY FRAME STYLE 9153629153 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | 9XT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |