MAUDE Adverse Event Report: EEZCARE MEDICAL CORP. MERIDIAN; 8" APM - 8LPM PUMP WITH FOAM BASE, PRODUCT CODE: FNM

Model Number MER-4500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Hip Fracture (2349)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

We had given efforts, but can not obtain any more information from importer, and the initial report from importer show only mention " adverse event" but not "product problem" (eg.Defects/malfunctions), also show as (b)(4) "advers event without identified device or use problem", so we think the adverse event might happened by some other cause.

Event Description

Patient was found face down next to her bed in the lowest position with the bolsters in place.Facility staff called 911 & end user was transferred from er to vipu with confirmed left hip fracture.

• Brand Name: MERIDIAN
• Type of Device: 8" APM - 8LPM PUMP WITH FOAM BASE, PRODUCT CODE: FNM
• Manufacturer (Section D): EEZCARE MEDICAL CORP.; no. 3-1, minquan street; tu-cheng disttrict; new taipei city, taipei 23679, tw 23679 ; TW 23679
• Manufacturer (Section G): EEZCARE MEDICAL CORP.; no. 3-1, minquan street; tu-cheng didtrict; new taipei city, taipei 23679, tw 23679 ; TW 23679
• Manufacturer Contact: david chen ; no. 3-1, minquan street; tu-cheng district; new taipei city, taipei 23679, tw 23679 ; TW 23679
• MDR Report Key: 7786205
• MDR Text Key: 117207565
• Report Number: 3003801933-2018-00003
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/19/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MER-4500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2018
• Distributor Facility Aware Date: 06/27/2018
• Device Age: 7 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/19/2018
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 92 YR
• Patient Weight: 42