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

Catalog Number 04P73-04

Device Problems Device Inoperable (1663); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.

Event Description

On (b)(6) 2018, abbott point of care (apoc) was contacted by a customer reporting that downloader sn (b)(4) was shortening out and smoking.The customer confirmed they are using the correct cable that came with the downloader.The product was replaced at no charge and returning for investigation along with its cable and power supply.There are no injuries associated with this event.Per i-stat1 system manual: art: (b)(4), rev.Date: (b)(6) 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.

Event Description

Na.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 06/01/2018.The customer reported that downloader recharger (drc) s/n (b)(4) has shorted out and emitted smoke.A waxy light-yellow substance leaked out from the vents under the drc.The customer confirmed that they are using the correct cable that came with the drc.While the customer complaint was not confirmed in that no smoke was emitted during failure analysis, a defective component u12 was discovered which would have caused a low analyzer voltage output on the drc and potentially caused the drc to emit smoke.

• 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
• MDR Report Key: 7425955
• MDR Text Key: 105432783
• Report Number: 2245578-2018-00132
• Device Sequence Number: 0
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2018
• 2 Devices were Involved in the Event: 1 2

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 06/01/2018
• Supplement Dates FDA Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1