MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-24 for NATUS EDX ELECTROMYOGRAPH SYSTEM 982A0597 manufactured by Natus Neurology, Incorporated.
[52940798]
This adverse event was registered internally as a complaint (reference (b)(4)) for further investigation by natus. Based on a service call initiated on july 20, 2016, the customer requested that a natus field service representative perform an onsite evaluation of the equipment but continued to use the equipment. The field service representative evaluation occurred on july 29, 2016 and found that the emg system base was not functioning properly. On that date, the customer informed the field service representative of this adverse event. The device history record for emg system serial number (b)(4) was reviewed. All the system components met the manufacturing specifications at the time of release. Product componentry was returned to natus for further evaluation and found that a transformer had failed within the base unit which resulted in the reduction of the electrical stimulation function of the system. Patient files supplied by the customer were evaluated by a trained clinician. A risk assessment performed by natus personnel concluded that input and output functions were inconsistent with expected results that trained users should recognize. Regarding the patient in question, following an initial request for information made on august 4, 2016, the customer reported on (b)(6) 2016 that no actual medical intervention was required.
Patient Sequence No: 1, Text Type: N, H10
[52940799]
Customer reported that their emg system is not getting any motor responses and stimulation sensories are low. This may have resulted in a misdiagnosis for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2016-00010 |
| MDR Report Key | 5901498 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-24 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-07-27 |
| Date Mfgr Received | 2016-07-29 |
| Device Manufacturer Date | 2016-02-26 |
| Date Added to Maude | 2016-08-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RANDALL MOOG |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088298802 |
| Manufacturer G1 | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATUS EDX ELECTROMYOGRAPH SYSTEM |
| Generic Name | ELECTROMYOGRAPH SYSTEM |
| Product Code | IKN |
| Date Received | 2016-08-24 |
| Returned To Mfg | 2016-08-03 |
| Model Number | 982A0597 |
| Catalog Number | 982A0597 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEUROLOGY, INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-24 |