ALGO 5 NEWBORN HEARING SCREENER 000619

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-08-02 for ALGO 5 NEWBORN HEARING SCREENER 000619 manufactured by Natus Medical Incorporated.

MAUDE Entry Details

• Report Number: 3018859-2019-00007
• MDR Report Key: 8857955
• Report Source: USER FACILITY
• Date Received: 2019-08-02
• Date of Report: 2019-07-10
• Date of Event: 2019-05-26
• Date Mfgr Received: 2019-09-03
• Device Manufacturer Date: 2017-07-11
• Date Added to Maude: 2019-08-02
• 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 AVE SOUTH
• Manufacturer City: SEATTLE WA 98108
• Manufacturer Country: US
• Manufacturer Postal: 98108
• Manufacturer Phone: 2062685173
• Manufacturer G1: NATUS MEDICAL INCORPORATED
• Manufacturer Street: 5900 FIRST AVE 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

Device Details

• Brand Name: ALGO 5 NEWBORN HEARING SCREENER
• Generic Name: ALGO 5
• Product Code: GWJ
• Date Received: 2019-08-02
• Returned To Mfg: 2019-08-30
• 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 AVE SOUTH SEATTLE WA 98108 US 98108

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-08-02