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U.S. Department of Health and Human Services

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

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EEZCARE MDICAL CORP. MERIDIAN; 8" APM SYSTEM, Back to Search Results
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.
 
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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 Key7573730
MDR Text Key110234777
Report Number3003801933-2018-00002
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Number4800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2018
Distributor Facility Aware Date05/01/2018
Device Age9 MO
Date Report to Manufacturer05/21/2018
Initial Date Manufacturer Received 05/21/2018
Initial Date FDA Received06/06/2018
Supplement Dates Manufacturer Received05/21/2018
Supplement Dates FDA Received06/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age80 YR
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