FDA Adverse Event Malfunction Summary report: N

2243471-2019-00014

MDR report key: 8451593 · Received March 26, 2019

Report

Report Number: 2243471-2019-00014
Event Type: Malfunction
Date Received: March 26, 2019
Date of Event: December 17, 2018
Report Date: March 26, 2019
PMA / PMN Number: BK140195
Removal / Correction Number: NA
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

FOR THE CUSTOMER'S INSTRUMENT (SERIAL ID (B)(4)), THE STOP DISCS AND O-RINGS AT THE FAILING POSITIONS WERE REPLACED ON PROCESSING MODULE B. THE MATERIAL HAS BEEN REQUESTED BACK FOR FURTHER INVESTIGATION WITH THE SUPPLIER. THE DROPLETS OBSERVED AROUND THE HEATING STATIONS WERE CLEANED BY THE LOCAL FIELD SERVICE ENGINEER. THE ISSUE HAS BEEN SOLVED WITH THESE SERVICE ACTIONS AND THE INSTRUMENT IS RUNNING WITHOUT ISSUES WITH PASSING TIGHTNESS CHECK RESULTS AND WITH NO EVIDENCE OF LEAKAGE. CORRECTIVE AND PREVENTIVE ACTIONS WILL BE IMPLEMENTED AS APPROPRIATE. (B)(4).

Description of Event or Problem · 1

A (B)(4) FIELD SERVICE ENGINEER (FSE) PERFORMED A TIGHTNESS CHECK ON A CUSTOMER'S COBAS 8800 SYSTEM (SERIAL ID (B)(4)), WHICH FAILED FOR PROCESSING MODULE B. THE FSE REPLACED THE STOP DISCS AND O-RINGS AT THE FAILING POSITIONS, THEN RE-PERFORMED THE TIGHTNESS CHECK, WHICH PASSED. ADDITIONALLY, IMAGES ON THE PROCESSING MODULE DECKS WERE PROVIDED AND SHOWED EVIDENCE OF LEAKAGE/DROPLETS ON THE FRONT HEATING STATION. NO HARM OR INJURY WAS ALLEGED WITHIN THE CASE.

Patients

Seq	Age	Sex	Outcome	Treatment
1