MAUDE Adverse Event Report: EEZCARE MEDICAL CORP. MERIDIAN; 8 HOMECARE APM

Model Number MER-5800

Device Problems Fail-Safe Design Failure (1222); Leak/Splash (1354)

Patient Problems Contusion (1787); Fall (1848)

Event Type  Injury  

Event Description

Two cells were leaking on the device, 9 and 10, that are flat.The patient slid out of his bed face down onto his head.The patient had a contusion on his head.He is a vegetative patient that doesn't move.They had one bolster on the opposite side only, the side the patient fell did not have a bolster.The facility said no audible or visible alarm was going off.

• Brand Name: MERIDIAN
• Type of Device: 8 HOMECARE APM
• Manufacturer (Section D): EEZCARE MEDICAL CORP.; no. 3-1, minquan street; tu-cheng district; new taipei city taipe, 23679 ; TW 23679
• MDR Report Key: 7432207
• MDR Text Key: 105517374
• Report Number: 3012316249-2018-00019
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MER-5800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2018
• Distributor Facility Aware Date: 03/26/2018
• Date Report to Manufacturer: 04/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other