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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 02/10/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
Event Description
It was reported that during setup, the battery charger was not charging the battery.There was backup device available and no delay or complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The reported device, intended for use in treatment, was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.
 
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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 Key11415552
MDR Text Key239431498
Report Number1643264-2021-00889
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,foreig
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
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? Yes
Date Manufacturer Received03/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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