MAUDE Adverse Event Report: ABBOTT POINT OF CARE MARTEL PRINTER. I-STAT1 ANALYZER

Catalog Number 06F23-91

Device Problems Overheating of Device (1437); Smoking (1585)

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

Event Date 09/25/2014

Event Type  malfunction  

Event Description

On (b)(6) 2013, abbott point of care was contacted by a customer who reported that a martel printer began to smoke, overheated, and stated it was warm to touch.The martel printer for the i-stat1 analyzer is discontinued at this time.Based on the information available at the time, there were no injuries associated with this event.

Manufacturer Narrative

(b)(4).

Event Description

Na.

Manufacturer Narrative

(b)(4).The investigation was completed on 12/17/2014.The printer was uncased, and burnt electronic components were found on its pcba.These electronic components (resistors) would have emitted smoke and would have cause the printer to become warm to the touch at the time of their failure.There is insufficient evidence to determine the cause of the failure of the electronic components, given the martel printer rechargeable battery utilized with the unit at the time of the event was not received for failure analysis.

• Brand Name: MARTEL PRINTER. I-STAT1 ANALYZER
• Type of Device: MARTEL PRINTER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 660
• Manufacturer (Section G): MARTEL INSTRUMENTS; durham, england DH9 9XG; UK DH9 9XG
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 4163837
• MDR Text Key: 4772969
• Report Number: 2245578-2014-00069
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 06F23-91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2014
• 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