MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT DOWNLOADER RECHARGER; DOWNLOADER/RECHARGER

Catalog Number 04P73-04

Device Problem Overheating of Device (1437)

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

Event Date 06/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, abbott point of care (apoc) was contacted by a customer regarding analyzers that became very hot to touch when placed in the downloader/recharger ((b)(4)).The analyzers wer using rechargeable batteries at the time of the event.The product (drc) was replaced at no charge and returning for investigation along with its cable and power supply.Per i-stat1 system manual: art: 714368-00k, rev.Date: 02-aug-2012: the downloader/recharger can recharge a rechargeable battery in the analyzer.If the analyzer contains a rechargeable battery, the battery begins recharging automatically as soon as the analyzer is placed in the downloader/recharger.The downloader/recharger also has a compartment for recharging a rechargeable battery outside the analyzer.Placing an analyzer in a downloader/recharger will automatically initiate recharging of the rechargeable battery.The indicator light on top of the downloader/recharger will be green (trickle charge), red (fast charge), or blinking red (fast charge pending) when an analyzer with a rechargeable battery is placed in the downloader/recharger.As well, placing a rechargeable battery into the recharging compartment will automatically initiate trickle recharging.The indicator light near the recharging compartment will be green when a rechargeable battery is placed in the compartment.There are no injuries associated with this event.

Manufacturer Narrative

(b)(4).The investigation was completed on 09/01/2016.The cause of the customer complaint was due to an electronic component failure.

Event Description

Na.

• Brand Name: I-STAT DOWNLOADER RECHARGER
• Type of Device: DOWNLOADER/RECHARGER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): FLEXTRONICS MANUFACTURING (SINGAPORE); pte ltd; 1 kallang place; singapore 33921 1; SN 339211
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 5757416
• MDR Text Key: 49062883
• Report Number: 2245578-2016-00042
• Device Sequence Number: 0
• Product Code: JQP
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04P73-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1