MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-02-11 for POWERED PATIENT TRANSPORT DEVICES RPS350-2 manufactured by Invacare Suzhou.
[19021963]
(b)(4). The dealer reported that the rps350-2 patient transport lift actuator was not functioning properly, and only one leg would open. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3004493922-2013-00310 |
MDR Report Key | 2955983 |
Report Source | 08 |
Date Received | 2013-02-11 |
Date of Report | 2013-02-11 |
Date Mfgr Received | 2013-01-16 |
Date Added to Maude | 2013-04-24 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | ROSARIO SWING |
Manufacturer Street | ONE INVACARE WAY |
Manufacturer City | ELYRIA OH 44035 |
Manufacturer Country | US |
Manufacturer Postal | 44035 |
Manufacturer Phone | 8003336900 |
Manufacturer G1 | INVACARE SUZHOU |
Manufacturer Street | UNIT 28 ZONE,200 SUHONG RD SUZHOU INDUSTRIAL PARK |
Manufacturer City | JIANGSU, P.R.C. 215021 |
Manufacturer Country | CH |
Manufacturer Postal Code | 215021 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | POWERED PATIENT TRANSPORT DEVICES |
Generic Name | 890.5150 |
Product Code | ILK |
Date Received | 2013-02-11 |
Model Number | RPS350-2 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INVACARE SUZHOU |
Manufacturer Address | UNIT 28 ZONE,200 SUHONG RD SUZHOU INDUSTRIAL PARK JIANGSU, P.R.C. 215021 CH 215021 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2013-02-11 |