MAUDE Adverse Event Report: WELCH ALLYN INC MOBILE SCALE W/HANDRAIL, NA_PCORD; SCALE, STAND-ON, PATIENT

Model Number	5002-XX-B
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The welch allyn masted scales are intended to be used by clinicians for weighing patients up to 660 pounds for model 5122, up to 880 pounds for models 5002 and 6002.Masted scales can make contact with a patient¿s hands and feet.Contact duration is intended to be limited to less than 30 seconds.The customer was provided the part # for a replacement power cord.Although there was no reported injury with this event, if the report of a damaged power cord with exposed wires were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
Customer reported the power cord had exposed wires.This incident was captured under complaint ref # (b)(4).

• Brand Name: MOBILE SCALE W/HANDRAIL, NA_PCORD
• Common Device Name: SCALE, STAND-ON, 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: 20805526
• Report Number: 1316463-2024-00159
• Device Sequence Number: 9831309
• Product Code: FRI
• UDI-Device Identifier: 00732094227260
• UDI-Public: 732094227260
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/28/2024

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: 5002-XX-B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/28/2024
• 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