MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2014-04-10 for MAINFRAME RESPONSE 2.0 8252001IP manufactured by Medtronic Xomed, Inc..
[4223725]
It was reported that the nim was making? Constant noise.? This issue occurred approximately 1. 5 hours into case (surgery unknown) and resulted in the site cancelling the case due to too much artifact. Reportedly, "the nim2. 0 was working fine for about an hour into the case. It randomly starting beeping on all channels and then [the users] notice[d] the box had moved from its original location. They confirmed electrodes were connected, and wrapped the box in a towel. They still received random responses even when not touching the patient. " the follow-up contact was not sure of any details about the potentially rescheduled surgery or clinical impact, and the initial report indicated there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[11812871]
This device is used for therapeutic purposes. (b)(4). The product has not been returned for analysis. Method: no testing methods performed.
Patient Sequence No: 1, Text Type: N, H10
[22908502]
The device was returned on (b)(4) 2014. The device was analyzed on (b)(4) 2014. The product analysis states,? Shake test was performed on the mainframe; no loose parts were heard. The interface, simulator and probe were connected and the mainframe turned on; boot-up sequence completed with no errors. Touchscreen responded. A monitoring mode was selected using all available channels. Each channel was stimulated in turn; normal and appropriate responses were seen on all channels. The stim setting was changed using the probe; system responded appropriately. Electrode check was within acceptable ranges for all channels, stim 1 and 2, and ground. The unit was placed in the burn-in oven for 24 hours in an attempt to duplicate the failure but it functioned normally.? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101039480]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2014-00079 |
| MDR Report Key | 3738435 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-04-10 |
| Date of Report | 2014-03-19 |
| Date of Event | 2014-03-19 |
| Date Mfgr Received | 2014-05-07 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2014-04-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY CORRALES |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328138 |
| 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 RESPONSE 2.0 |
| Generic Name | STIMULATOR, NERVE |
| Product Code | IKN |
| Date Received | 2014-04-10 |
| Returned To Mfg | 2014-04-24 |
| Model Number | 8252001IP |
| Catalog Number | 8252001IP |
| Lot Number | 48446200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2014-04-10 |