MAUDE Adverse Event Report: UNKNOWN BREAST PUMP

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2015

Event Type  Injury  

Event Description

(b)(4).Spectra 9plus breast pump, s/n (b)(4).Pump battery (internal) charged completely.Used pump cordless, as well as plugged in, for approximately 3 total hours, in increments of 5-10 minutes over the course of several days.Once battery was completely discharged, pump would no longer work, with or without power adapter.Company is providing a replacement pump and i will return current pump.

• Brand Name: BREAST PUMP
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5022019
• MDR Text Key: 23732194
• Report Number: MW5055672
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BREAST PUMP STOPPED WORKING AFTER 3 HOURS OF USE.
• Patient Age: 39.000 YR