MAUDE Adverse Event Report: GIVEN LTD (ISRAEL) BRAVO PH RECORDER REFURBISHED; ELECTRODE, PH, STOMACH

Model Number RFB-0450

Device Problem Calibration Problem (2890)

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

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter they have a bravo recorder which has a mismatch error.The capsule was in a patient when this issue was noticed.There was no injury to the patient or user, and a repeat procedure will be required.

Manufacturer Narrative

Evaluation summary: one recorder was received for evaluation and was inspected for external damage.According to the reported information, the customer successfully calibrated the recorder with the capsule, but then mistakenly entered the calibration menu instead of "start study", then selected "calibrate capsule" a second time, followed by "record study" which led to the error of "id mismatch".The product performed to specification and the issue is attributed to user mishandling.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: BRAVO PH RECORDER REFURBISHED
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN LTD (ISRAEL); 2 hacarmel st.; new industrial pob 258,; yoqneam ; IS
• Manufacturer (Section G): GIVEN LTD (ISRAEL); 2 hacarmel st.; new industrial pob 258,; yoqneam ; IS
• Manufacturer Contact: amy beeman ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 6269648
• MDR Text Key: 65508148
• Report Number: 9710107-2017-00040
• Device Sequence Number: 1
• Product Code: FFT
• 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,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFB-0450
• Device Catalogue Number: RFB-0450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Weight: 59