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

Catalog Number 04P73-04

Device Problems Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892)

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

Event Date 03/25/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, abbott point of care (apoc) was contacted by a customer regarding rechargeable batteries that became hot to the touch while charging in the analyzer when placed in the downloader/recharger (drc).The customer states when the rechargeable battery was removed from the handheld and replaced by 9 volt batteries the analyzer was fine.The issue appears to be when the battery was charged in the drc while in the analyzer.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.The customer was asked to return the drc along with it's associated rechargeable battery pack for investigation.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The investigation was completed on 06/23/2015.Product (drc-66223) was tested and is functioning according to specification.

• Brand Name: I-STAT DOWNLOADER RECHARGER
• Type of Device: DOWNLOADER/RECHARGER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 660
• Manufacturer (Section G): FLEXTRONICS MANUFACTURING (SINGAPORE); pte ltd; 1 kallang place; singapore 3392 11; SN 339211
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 4661117
• MDR Text Key: 17632865
• Report Number: 2245578-2015-00012
• Device Sequence Number: 1
• 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: 03/25/2015

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 Catalogue Number: 04P73-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 04/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2013
• 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