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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 Failure to Charge (1085)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the battery charger of the spider 2 tenet was not charging.No case reported; therefore, there was no patient involvement.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 Key11256301
MDR Text Key229611723
Report Number1643264-2021-00334
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,health
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2021
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 Manufacturer01/27/2021
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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