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

Catalog Number 06F23-45

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

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2018

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 shorting out and smoking.The customer stated that the cable was plugged into the downloader and then they plugged it into the pc when the puffs of smoke came out.Product was immediately turned off and unplugged.There are no injuries associated with this event.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.

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on 09/11/2018.The customer reported that serial downloader/recharger (drs) s/n drs-43030 emitted smoke when it was plugged into a power source.Drs s/n drs-43030 has not been returned to flex; therefore, no evaluation could be performed.The customer was reminded on three separate occasions to return the hardware to flex.A rocketware search spanning six months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.

• Brand Name: I-STAT DOWNLOADER RECHARGER, SERIAL
• Type of Device: DOWNLOADER/RECHARGER. SERIAL
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 7591675
• MDR Text Key: 111320276
• Report Number: 2245578-2018-00171
• 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: 09/19/2018
• 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: 06F23-45
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1