FDA Adverse Event
Malfunction
Summary report: N
AURICAL AUD/PMM, 1081
MDR report key: 8934276
·
Received August 27, 2019
Report
- Report Number
- 9612197-2019-00008
- Event Type
- Malfunction
- Date Received
- August 27, 2019
- Date of Event
- August 6, 2019
- Report Date
- September 23, 2019
- Manufacturer
- NATUS MEDICAL DENMARK (GN OTOMETRICS)
- Product Code
- EWO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
PRODUCT WAS RETURNED AND EVALUATED. PROBLEM DESCRIPTION: INTERMITTENT CONNECTION - FAILED DURING TIME TEST. OVER HEATING - UNABLE TO REPRODUCE ERROR. FREEFIT BATTERY COVER DAMAGED. RESOLUTION: SERVICE REPLACEMENT UNIT. TRANSFERRED CALIBRATION SETTINGS. REPLACED FREEFIT BATTERY COVER. DEVICE REPAIRED AND SHIPPED BACK TO THE CUSTOMER.
Additional Manufacturer Narrative · 1
ISSUE AFFECTING AURICAL AUD/PMM, 1081, SN: (B)(4). DEVICE DISCONNECTED & BURNING SMELL. PATIENT INFORMATION - NO PATIENT INVOLVEMENT. PMA/510(K) - THIS DEVICE IS EXEMPT.
Description of Event or Problem · 1
ISSUE AFFECTING AURICAL AUD/PMM, 1081, SN: (B)(4). DEVICE DISCONNECTED & BURNING SMELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 728006 | AURICAL AUD/PMM, 1081 | AURICAL AUD/PMM, 1081 | EWO | NATUS MEDICAL DENMARK (GN OTOMETRICS) | 8-04-14500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |