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 03/02/2021

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 reporting that i-stat 1 downloader recharger drc-74105 had small sparks appear near the charging contacts when docking an i-stat1 analyzer, sn (b)(4).Customer states the correct power supply was being used.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.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: 853890 the investigation was completed on 25-may-2021.The customer reported that i-stat1 downloader recharger (drc) (b)(6) had "sparks" appear near the charging contacts when docking i-stat1 analyzer (b)(6) on the drc.The customer further reported that there is a scorch mark right above the contact pins of the drc and on the recharge contact pads of the analyzer.The customer complaint was confirmed upon visual examination of drc-74105 and analyzer (b)(6): a scorch mark was observed above the contact pins and recharge contact pads, respectively.Functional tests to ensure correct charging capabilities were performed on the drc and the analyzer, and it was determined that the drc was able to charge the returned analyzer as expected.No hot to touch or warm conditions were noted, and no additional scorch marks were observed on either the analyzer or the drc.The drc and analyzer were uncased, and all internal components were inspected.No signs of contamination, damage, or burnt components were noted.The recharge contact pads of the analyzer did have some charring and debris from the "spark".Critical components such as fuses and transistors, were examined in depth via engineering analysis techniques, and all components were determined to be functioning as per specification.The conclusion of this investigation is that the drc and the analyzer functioned according to specifications during failure analysis.It should be noted that the drc power cables/adapters and the i-stat1 rechargeable power pack have not been returned for investigation, and there is insufficient evidence to rule out these items as having contributed to the complaint.

Event Description

Na.

• 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: 11448816
• MDR Text Key: 260956184
• Report Number: 2245578-2021-00021
• 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: 06/02/2021

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: 04/15/2021
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1