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

Model Number MER-5800

Device Problems Deflation Problem (1149); Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

We had given efforts, but can not obtain any more information or suspect device return from initial reporter or importer for evaluation.We had simulate the situation as "describe event or problem" many times, even with the worst condition, but the result show that "the patient slid out of his bed face down onto his head" did not happen.The suspect device (air pump) will show visible low pressure alarm if the two cells were leaking on the device,9 and 10, that are flat.So reasonable conclusion that the root cause of adverse event happening is not the suspect device mer-5800, but some unknown situation that had not obtained in this report.As the attached file "adverse event simulation test report".

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 has 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 districr,; new taipei city,, taipei 23679 ; TW 23679
• Manufacturer (Section G): EEZCARE MEDICAL CORP.; no. 3-2, minquan street,; tu-cheng didtrict,; new taipei city,, taipei 23679 ; TW 23679
• Manufacturer Contact: david chen ; no. 3-1, minquan street,; tu-cheng districr,; new taipei city, taipei 23679 ; TW 23679
• MDR Report Key: 7533800
• MDR Text Key: 109005363
• Report Number: 3003801933-2018-00001
• 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
• Remedial Action: Repair
• 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: 04/16/2018
• Initial Date FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other