MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-30 for ASSEMBLY, 9300XSP L/S W/APSW T 009300XSPP manufactured by Integra, Burlington.
[2261851]
The biomedical engineer reported "the unit started smoking when they turned it on; the front wheel on unit was installed backwards. An adaptive socket, to fit the headlamps, was installed but was installed backwards and the light beam caused it to overheat and there was no light. There was no smoke but the smell of melted plastic. The biomedical engineer was unable to confirm who installed for the adaptive socket. There were no injuries.
Patient Sequence No: 1, Text Type: D, B5
[9305488]
The device involved in the reported incident has been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1222895-2011-00025 |
MDR Report Key | 2276123 |
Report Source | 05,06 |
Date Received | 2011-09-30 |
Date of Report | 2011-09-30 |
Date Mfgr Received | 2011-09-19 |
Date Added to Maude | 2012-06-28 |
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 | BIOMEDICAL ENGINEER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 0 |
Event Location | 0 |
Manufacturer Contact | CAREN FERNANDEZ |
Manufacturer Street | 315 ENTERPRISE DR |
Manufacturer City | PLAINSBORO NJ 08536 |
Manufacturer Country | US |
Manufacturer Postal | 08536 |
Manufacturer Phone | 6099362341 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ASSEMBLY, 9300XSP L/S W/APSW T |
Generic Name | NONE |
Product Code | ITY |
Date Received | 2011-09-30 |
Catalog Number | 009300XSPP |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTEGRA, BURLINGTON |
Manufacturer Address | BURLINGTON MA 01803 US 01803 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2011-09-30 |