MAUDE Adverse Event Report: SPECTRA SPECTRA S1 PLUS; PUMP, BREAST, POWERED

Model Number	SPECTRA S1 PLUS
Health Effect - Clinical Codes	Pain (1994); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The breast pump stopped turning on during normal use.My wife uses this breast pump to express milk used to feed our infant child.The breast pump was only 3 months old and under warranty.We contacted the manufacturer (spectra) about the defective unit (spectra s1 plus).Spectra has still not provided us with a replacement pump.This is causing my wife severe emotional and physical pain as she struggles to feed our child.Additionally, my wife has an oversupply of breast milk and the unexpected field failure of this medical device puts her at risk of mastitis.Spectra also does not follow their posted hours per the website and is difficult to contact.Fda safety report id# (b)(4).

• Brand Name: SPECTRA S1 PLUS
• Common Device Name: PUMP, BREAST, POWERED
• Manufacturer (Section D): SPECTRA
• MDR Report Key: 15925374
• Report Number: MW5113649
• Device Sequence Number: 14758762
• Product Code: HGX
• UDI-Device Identifier: 08809108011091
• UDI-Public: 08809108011091
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

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: SPECTRA S1 PLUS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MESALAMINE; PRENATAL VITAMIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White