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 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

Apoc incident # (b)(4).The investigation was completed on (b)(4) 2019.The customer reported that downloader recharger (drc) s/n (b)(4) emitted smoke.The customer also reported that an i-stat rechargeable power pack s/n (b)(4) was charging inside the drc at the time when smoke was observed.The customer complaint was confirmed, and the cause was determined to be the failure of components d14 and q1 on the main board of the drc.The likely cause of the failure of components d14 and q1 was the use of a 45v power supply at the customer site, rather than the 12v power supply that was furnished with the drc.The rechargeable battery pack was not returned; therefore, it is unknown if the battery pack caused or contributed to the complaint.A rocketware search spanning six months revealed one related incident and no evidence of a trend.No deficiency has been identified.

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) that emitted smoke and no visible fire when connected to the power supply cable and adapter supplied with the drc.The customer states that smoke came after connecting the cable with adapter to the power-supply & drc.The cable with adapter was then removed and observed if it was the correct cable.There were no damages seen to the product.The product was replaced at no charge and returning for investigation.The drc unit and rechargeable power pack were 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.

• 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
• Manufacturer (Section G): FLEXTRONICS MANUFACTURING (SINGAPORE); pte ltd; 1 kallang place; 33921 1; SN 339211
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 8736062
• MDR Text Key: 160199700
• Report Number: 2245578-2019-00162
• Device Sequence Number: 0
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2019
• 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: 04P73-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1