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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS; PEDIATRIC DISPOSABLE HANDLE 3/BATTERY

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SALTER LABS SALTER LABS; PEDIATRIC DISPOSABLE HANDLE 3/BATTERY Back to Search Results
Model Number 2016.C
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2023
Event Type  malfunction  
Event Description
Lights not coming on, multiple laryngoscope handles. "we were trying to intubate a baby and the laryngoscope handle light wouldn't come on.We then grabbed a second handle and the light on that one wouldn't come on either this resulted in a delay of care.".
 
Manufacturer Narrative
Failure of the device delayed the intubation of the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.
 
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Brand Name
SALTER LABS
Type of Device
PEDIATRIC DISPOSABLE HANDLE 3/BATTERY
Manufacturer (Section D)
SALTER LABS
30 spur drive
el paso TX 79906
Manufacturer (Section G)
SALTER LABS
30 spur drive
el paso TX 79906
Manufacturer Contact
melissa brickley
2710 northridge dr nw suite a
grand rapids, MI 49544
6162598415
MDR Report Key18016401
MDR Text Key326720010
Report Number3000219639-2023-00035
Device Sequence Number1
Product Code CCW
UDI-Device Identifier00607411964428
UDI-Public00607411964428
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date 10/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2016.C
Device Catalogue Number2016.C
Device Lot Number013120ADPS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/26/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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