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 04/27/2021

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 (b)(4) caused a spark when i-stat 1 analyzer sn (b)(4) was docked.Customer states the downloader has a burnt mark near the gold pins and the analyzer has a burnt mark on the back near the gold pins.The product was replaced at no charge and returning for investigation along with power supply and analyzer that was docked at the time 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.

Event Description

Na.

Manufacturer Narrative

Apoc incident# (b)(4) the investigation was completed on 10-jun-2021.The customer reported i-stat downloader recharger drc-83127 caused a spark when i-stat 1 analyzer 379765 was docked.The customer also reported a burnt mark near the gold pins of the downloader and the gold pins on the back of the analyzer.The customer's complaint was confirmed via the burned marks on the surface of the drc near the recharge contact pins upon receipt.However, the analyzer showed no signs of burn marks during the inspection.Analyzer (b)(6) and drc (b)(6) functioned according to specifications during failure analysis.There is no evidence showing the customer was using the incorrect power adapter as per the power adapter picture they provided (located in the rocketware incident files).Furthermore, as the complaint rechargeable battery bod 2018-03 as well as the drc power cables and adapters have not been returned for investigation, there is insufficient evidence to rule out these items as having contributed to the complaint.A rocketware search spanning six months revealed one similar incident and no evidence of a trend.No deficiency has been identified.

• 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: 11777852
• MDR Text Key: 251665220
• Report Number: 2245578-2021-00040
• 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: 06/17/2021

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: 05/25/2021
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1