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 Consequences Or Impact To Patient (2199)

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, abbott point of care (apoc) was contacted by a customer regarding an analyzer that was placed in the downloader/recharger (drc) and became hot.The customer states that an analyzer was put into the drc and got hot.The customer removed the analyzer, swapped drcx and the analyzer no longer got hot.The analyzer was using rechargeable batteries at the time of the event.The product (drc) was replaced at no charge and returning for investigation.Per i-stat system manual: art: 714368-00k, rev.Date: 02-aug-12: 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.At this time there is no evidence of a confirmed malfunction and product was replaced at no charge.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 04/06/2016.The customer reported that an analyzer was warm to touch when placed onto downloader recharger (drc) s/n (b)(4), and the drc was hot to touch.Drc s/n (b)(4) has not been returned to flextronics; therefore, no evaluation could be performed.

Event Description

N/a.

• 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: 5386541
• MDR Text Key: 36771653
• Report Number: 2245578-2016-00002
• 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: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04P73-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2015
• 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