MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-08-23 for MAINFRAME 8252001IP RESPONSE 2.0 W/INCRE manufactured by Medtronic Xomed, Inc..
[3832773]
It was reported that the mainframe screen was? Going blank and lines showing up?. Follow-up with the customer found the patient had been anesthetized prior to testing the equipment. When they realized the equipment would not work and they cancelled the procedure, they had to wake up the patient. It is unknown if the procedure was rescheduled. There was no report of patient injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[11014206]
This device is used for therapeutic purposes. (b)(4): the device was returned for evaluation and repair. The product analysis could not verify the reported complaint? Going blank and lines showing up? ; however, the cpu battery was out of specification which may cause the system to not boot-up properly. The device was repaired,tested t o specifications, and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00501 |
| MDR Report Key | 3306052 |
| Report Source | 06,07 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-08-13 |
| Date Mfgr Received | 2013-08-13 |
| Device Manufacturer Date | 2008-10-16 |
| Date Added to Maude | 2013-08-23 |
| 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 | HOSPITAL SERVICE TECHNICIAN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE AYALA |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328372 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAINFRAME 8252001IP RESPONSE 2.0 W/INCRE |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2013-08-23 |
| Returned To Mfg | 2013-08-01 |
| Model Number | 8252001IP |
| Catalog Number | 8252001IP |
| Lot Number | 58175800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-23 |