MAUDE Adverse Event Report: PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER; CLINICAL CHEMISTRY ANALYZER

Model Number 2700

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the analyzer would not power on and was returned for investigation.During the complaint investigation, the returned analyzer would not power on (as reported) but was observed to be warm.This observation (made on (b)(6) 2020) escalated the event to be reportable.The customer did not make any thermal allegation.There were also no allegations of patient/user harm.

Event Description

The customer reported that the analyzer would not power on and was returned for investigation.During the complaint investigation, the returned analyzer was observed to be warm.This observation escalated the event to be reportable.The customer did not make any thermal allegation.

• Brand Name: CARDIOCHEK PLUS ANALYZER
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): PTS DIAGNOSTICS; 7736 zionsville road; indianapolis, in
• Manufacturer (Section G): PTS DIAGNOSTICS; 7736 zionsville road; indianapolis, in
• Manufacturer Contact: brandon unruh ; 7736 zionsville road; indianapolis, in ; 8705610
• MDR Report Key: 9775474
• MDR Text Key: 193003153
• Report Number: 1836135-2020-00017
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00381932700016
• UDI-Public: (01)00381932700016(8012)111
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2700
• Device Catalogue Number: 2700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1