NON AC-POWERED PATIENT LIFT
Report
- Report Number
- 1525712-2012-00949
- Event Type
- Malfunction
- Date Received
- July 12, 2012
- Date of Event
- June 18, 2012
- Report Date
- July 18, 2012
- Manufacturer
- UNKNOWN
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
(B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL PRONTO, SERIAL NUMBER/DATE CODE AND AGE ARE UNKNOWN. THE CONSUMER IS A (B)(6) FEMALE. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CUSTOMER ALLEGED NO INJURY. THE CUSTOMER ALLEGED MALFUNCTION; THE ON/OFF SWITCH SHORTS OUT AND THEN COMES BACK ON. THE CUSTOMER'S DEALER HAS SINCE GONE OUT OF BUSINESS. THE CUSTOMER WAS PROVIDE DEALERS IN HER AREA TO ASSIST IN RESOLVING THE ISSUE. THE ON/OFF SWITCH SHORTING OUT IS A POTENTIAL TO STRAND THE CUSTOMER IN AN UNSAFE ENVIRONMENT AND A POTENTIAL FOR INJURY. MDR FILED FURTHER EVALUATION AND INVESTIGATION IS PROVIDED BY INVACARE.
(B)(4). INITIAL PR #(B)(4) ISSUED MFG. REPORT # 1525712-2012-00949 WITH THE MANUFACTURER LISTED AS INVACARE (B)(4). THE ACTUAL MANUFACTURER IS UNKNOWN. THE BRAND NAME WAS ORIGINAL LISTED AS A POWERED WHEELCHAIR, COMMON DEVICE NAME OF 890.3860. THE CORRECTION IS A NON- AC POWERED PATIENT LIFT, COMMON DEVICE NAME 880.5510. THE INITIAL REPORTER WAS LISTED AS (B)(6), CORRECT REPORTER IS (B)(6). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9805P, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1024492 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. THE CONSUMER IS A (B)(6) FEMALE. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CONSUMERS SON CALLED STATING THAT THE SCREWS NEAR THE HYDRAULIC PUMP ON THE 9805P LIFT ARE ALLEGEDLY COMING UNSCREWED AND SNAPPING IN HALF. THE FAMILY IS WORKING WITH A DEALER TO OBTAIN A NEW RX FOR A REPLACEMENT LIFT THROUGH MEDICARE. THE LIFT HAS ALLEGEDLY BROKEN IN MID TRANSFER BUT CONSUMER WAS NOT DROPPED. NO INJURY ALLEGED. (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL PRONTO, SERIAL NUMBER/DATE CODE AND AGE ARE UNKNOWN. THE CONSUMER IS A (B)(6) FEMALE. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CUSTOMER ALLEGED NO INJURY. THE CUSTOMER ALLEGED MALFUNCTION; THE ON/OFF SWITCH SHORTS OUT AND THEN COMES BACK ON. THE CUSTOMER'S DEALER HAS SINCE GONE OUT OF BUSINESS. THE CUSTOMER WAS PROVIDE DEALERS IN HER AREA TO ASSIST IN RESOLVING THE ISSUE. THE ON/OFF SWITCH SHORTING OUT IS A POTENTIAL TO STRAND THE CUSTOMER IN AN UNSAFE ENVIRONMENT AND A POTENTIAL FOR INJURY. MDR FILED FURTHER EVALUATION AND INVESTIGATION IS PROVIDED BY INVACARE.
END USER STATES: "SCREWS NEAR THE HYDRAULIC PUMP ARE COMING UNSCREWED. CUSTOMER ALSO ALLEGES THAT THE METAL ON THE MAST IS BREAKING OFF. CUSTOMER ALLEGES THAT HE HAS DONE HOME REPAIRS ON THE LIFT SINCE THIS HAS HAPPENED TO GET IT TO WORK FOR HIS MOTHER.
END USER STATES: "SCREWS NEAR THE HYDRAULIC PUMP ARE COMING UNSCREWED. CUSTOMER ALSO ALLEGES THAT THE METAL ON THE MAST IS BREAKING OFF. CUSTOMER ALLEGES THAT HE HAS DONE HOME REPAIRS ON THE LIFT SINCE THIS HAS HAPPENED TO GET IT TO WORK FOR HIS MOTHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NON AC-POWERED PATIENT LIFT | 880.5510 | FSA | UNKNOWN | 9805P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 DA | Other |