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

Catalog Number 04P73-04

Device Problem Fail-Safe Problem (2936)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019, abbott point of care (apoc) was contacted by a customer reporting that downloader (b)(4) felt hot when docked and one of the rechargeable batteries is slightly distorted.When the same analyzers were docked in other downloaders, there were no issues.The product was replaced at no charge and returning for investigation.There were no injuries reported.Per i-stat1 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.

Manufacturer Narrative

Apoc incident #: (b)(4).The investigation was completed on 08/22/2019.The customer reported that analyzers were hot to touch when docked on downloader recharger (drc) sn (b)(4), and the drc was hot to touch.Those analyzers were not hot to touch when docked on other downloaders.The customer also reported that one of the rechargeable batteries was slightly distorted.The drc was warm to touch during the evaluation.It was determined that the failure of component q1 on the main board of drc s/n (b)(4) caused the drc to become warm to touch and could potentially have caused the rechargeable battery in the analyzer to become hot to touch when the analyzer was docked on the drc at the customer site.A deficiency has been identified.A rocketware search spanning six months revealed one related incident and no evidence of a trend.No corrective or preventive action is required at this time.

• 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: 8775422
• MDR Text Key: 195924509
• Report Number: 2245578-2019-00171
• Device Sequence Number: 1
• 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: 08/23/2019

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: 08/16/2019
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1