MAUDE Adverse Event Report: WELCH ALLYN INC. 4802D SCALE, 1GM, STD CRAD, NA_PCORD; SCALE, PATIENT

Model Number	4802D-AX-XB
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The welch allyn pediatric/infant scale is intended to be used by clinicians for weighing patients from 0.35 oz to 44 lbs (10 g to 20 kg) and measuring patients up to 32 inches (81 cm), depending on the size of the scale cradle.The customer did not return the device for inspection.A replacement power cord was shipped to the customer.Although there was no adverse event reported, if a power cord/supply were to be damaged with exposed copper wires it could lead to a serious injury or death.Baxter is reporting this device malfunction.
Event or Problem Description
Customer reported the cord was separated at the power supply and wires were showing.

• Brand Name: 4802D SCALE, 1GM, STD CRAD, NA_PCORD
• Common Device Name: SCALE, PATIENT
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 21080682
• Report Number: 1316463-2025-00003
• Device Sequence Number: 20916283
• Product Code: FRW
• UDI-Device Identifier: 00732094227390
• UDI-Public: 732094227390
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4802D-AX-XB
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown