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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIDER2 24V BATTERY CHARGER; BATTERY, REPLACEMENT, RECHARGEABLE

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SMITH & NEPHEW, INC. SPIDER2 24V BATTERY CHARGER; BATTERY, REPLACEMENT, RECHARGEABLE Back to Search Results
Catalog Number 72203840
Device Problem Charging Problem (2892)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
It was reported that the spider battery charger was not changing from color orange.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issues were observed.A functional evaluation revealed the device's indicator diode would not change to charging mode when a test battery was installed.The fuse was checked with an ohmmeter and was open.The complaint was confirmed and the root cause is a blown fuse.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.
 
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Brand Name
SPIDER2 24V BATTERY CHARGER
Type of Device
BATTERY, REPLACEMENT, RECHARGEABLE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
MDR Report Key10839816
MDR Text Key216332456
Report Number1643264-2020-01825
Device Sequence Number1
Product Code MOQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 12/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72203840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Date Manufacturer Received10/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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