MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-07 for ALGO 5 NEWBORN HEARING SCREENER 000619 manufactured by Natus Medical Incorporated.
[128589053]
The entire algo5 system was requested for return to (b)(6) for evaluation and a replacement algo 5 system was provided to customer to prevent delay in screening. The device was received by (b)(6) medical for evaluation on (b)(6) 2017 and is under evaluation. If additional information is available (b)(6) medical will file a supplemental.
Patient Sequence No: 1, Text Type: N, H10
[128589054]
(b)(6) medical received a complaint on (b)(6) 2018. It was reported to (b)(6) that algo 5 hearing screener results were questionable to the user. Customer stated that patient passed hearing screen (left: pass, right: refer) but was later diagnosed as deaf and confirmed that equipment checks had passed prior to screening. There was no death, serious injury, delay in treatment, or environmental/safety concerns. (b)(6) technical service representative suggested customer to discontinue use of the device and requested answers to additional questions regarding the event. After the initial follow up with customer by (b)(6) technical service representative, it was confirmed that the screening was performed while the patient was sleeping and there was no sensor replacement or adhesion issues. The follow up confirmatory tested was completed on the same day as screen and the patient was diagnosed with bilateral hearing loss. The patients genetic testing indicated that parents have gene for hearing loss and the patient's older sister was born deaf.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00151 |
| MDR Report Key | 8049144 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-07 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-11-12 |
| Device Manufacturer Date | 2016-08-31 |
| Date Added to Maude | 2018-11-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALGO 5 NEWBORN HEARING SCREENER |
| Generic Name | ALGO 5 |
| Product Code | GWJ |
| Date Received | 2018-11-07 |
| Returned To Mfg | 2018-11-05 |
| Model Number | 000619 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-07 |