MAUDE Adverse Event Report: EEZCARE MDICAL CORP. MERIDIAN; 8" APM SYSTEM,

Model Number 4800

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

Patient Problems Contusion (1787); Fall (1848); Head Injury (1879)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

We had obtained the information said that " bed rails were not in use when the patient fell, no visible defect with the air mattress." and the device did not return from initial reporter or importer for evaluation.The air mattress system is a mature device in marketing and popular usage, we have confident that the root cause of adverse event happening is not caused by the device, but bed rails were not in use.

Event Description

The end-user fell out of bed sustaining a head injury and had to be transported by ambulance.The end-user received stitches.Bed rails were not in use when the patient fell.No visible defect with the air mattress.

Manufacturer Narrative

We had obtained the information said that bed rails were not in use when the patient fell, no visible defect with the air mattress, and the device had returned from customer to importer for inspection, but not returned to us (manufacturer).The importer had inspected the returned device 4800 serial number (b)(4), the result as the description of event " no visible defect with the air mattress." the air mattress system is a mature device in marketing and popular usage.We had confident that the root cause of adverse event happening should not cause by the device, but bed rails were not in use.

Event Description

The end-user fell out of bed sustaining a head injury and had to be transported by ambulance.The end-user received stitches.Bed rails were not in use when the patient fell.No visible defect with the air mattress.(supplemental report) customer returned a different serial number and different item of reported device.Serial number (b)(4) and item 4800 was returned for inspection.Inspector did not realize it was a different item/different serial number at time of report.Customer initially reported serial number (b)(4) and item mer-4500 in email, sent in a picture of serial number (b)(4), and returned serial number (b)(4) and item 4800.

• Brand Name: MERIDIAN
• Type of Device: 8" APM SYSTEM,
• Manufacturer (Section D): EEZCARE MDICAL CORP.; no. 3-1, minquan street,; tu-cheng district,; new taipei city,, taipei 23679 ; TW 23679
• Manufacturer (Section G): EEZCARE MEDICAL CORP.; no. 3-1, minquan street,; tu-cheng district,; new taipei city,, taipei 23679 ; TW 23679
• Manufacturer Contact: david chen ; no. 3-1, monquan street,; tu-cheng district,; new taipei city,, taipei 23679 ; TW 23679
• MDR Report Key: 7573730
• MDR Text Key: 110234777
• Report Number: 3003801933-2018-00002
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: No Information
• Device Model Number: 4800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2018
• Distributor Facility Aware Date: 05/01/2018
• Device Age: 9 MO
• Date Report to Manufacturer: 05/21/2018
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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; Other
• Patient Age: 80 YR