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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

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) 2021, abbott point of care (apoc) was contacted by a customer reported that i-stat 1 downloader recharger (b)(4) becomes hot to the touch.The customer removed the analyzer and the battery and allowed them to cool down.The analyzers pass the simulator test.Customer reports no issues with the analyzer or batteries when used in another downloader.The product was replaced at no charge and returning for investigation along with power supply and anlyzer that was docked at the tme of the event.There were no injuries reported.Customer is using recharge able batteries.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.

Event Description

Na.

Manufacturer Narrative

Apoc incident# (b)(4).The investigation was completed on (b)(6) 2021.The customer reported that analyzers (with rechargeable batteries) became hot to touch when docked in downloader recharger (drc) sn (b)(6), and the drc was hot to touch.The same analyzers and rechargeable batteries were not hot to touch when docked in another downloader.The customer confirmed that the correct power cord was used with the drc when the incident occurred.The conclusion of the investigation is that the complaint was confirmed, and the cause was determined to be failure of components q1 and d14 on the main board of drc s/n (b)(6).A deficiency has been identified.A rocketware search spanning six months revealed no similar incidents 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: 11958528
• MDR Text Key: 260958649
• Report Number: 2245578-2021-00052
• 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: 07/21/2021

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: 07/08/2021
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 07/16/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1