MAUDE Adverse Event Report: SUNNYVALE BRAVO PH RECDR; ELECTRODE, PH, STOMACH

Model Number FGS-0450

Device Problem Failure to Transmit Record (1521)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during an esophageal procedure, the account was unable to upload data from the recorder to the work station.A repeat procedure will be necessary due to the alleged device malfunction.The last known patient status is that she is stable.There was no harm or injury to the patient or user.No other known adverse events were reported.

Manufacturer Narrative

(b)(4).The mdr report was generated with the incorrect manufacture site.As a result, a new mdr will be filed under 9710107-2016-01164.

• Brand Name: BRAVO PH RECDR
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): SUNNYVALE; 540 oakmead parkway; sunnyvale CA 94085
• Manufacturer (Section G): SUNNYVALE
• Manufacturer Contact: sharon murphy ; 195 mcdermott rd; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6193344
• MDR Text Key: 62965447
• Report Number: 3004904811-2016-00133
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Device Lot Number: BR2-0201932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 82