MAUDE Adverse Event Report: CAREMED SUPPLY INC. MICROAIR MA600; THERAPEUTIC SUPPORT SURFACE

Model Number NA:MA600

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

This incident is being reported due to the alleged issue resulting in an adverse event.This incident is being escalated internally for further review.This device was over 1 year old at the time of this issue.This device was supplied and the supplier will be notified of the incident.Attempts to obtain additional information were unsuccessful.Based on the information available the service light on the device was illuminated and the device wasn't functioning properly during an initial report of a similar allegation on october 3rd, 2023 that didn't allege an adverse event.The service light can indicate an issue or that routine service is required after 8,760 hours of use.Based on the available information its unclear why the service light is illuminated.The user and caregivers appeared to have ignored the obvious indications of a product problem and continued using the device resulting in a pressure injury to the user.The manual for the device indicates this device can be used for patients who have an existing stage 1, 2, and 3 pressure ulcers, in conjunction with a policy on pressure area management.The allegation that the therapeutic support surface caused/contributed to the end user developing pressure ulcers cannot be verified.Pressure ulcers are injuries to skin and underlying tissue resulting from pressure on the skin when resting in a position for an extended period, and can occur regardless of the resting surface being used.Development of pressure ulcers is multifactorial.While the therapeutic support surface is designed to provide changes in the distribution of body pressure, the alleged malfunction of the device is only one of many contributing factors to the patient developing pressure ulcers.In addition to pressure, primary external causes include friction and shear.Individual risk factors play a key role in increasing the end user¿s susceptibility to pressure sores, examples include but are not limited to: end user size, weight, immobility, lack of sensory perception, incontinence, medical conditions affecting blood flow, poor nutrition and poor hydration.The management, treatment and prevention of pressure ulcers should be individualized and depends on the end user¿s medical history, risk factors and physical status.In all cases care is pivotal in pressure ulcer prevention.Education, clinical judgement and action based planning based on vulnerability are fundamental factors in the prevention and treatment.It is very important for the end user to reposition themselves, or to be repositioned, on a regular basis.It is the standard of care that the end user¿s condition should be monitored frequently and the care plan should be reviewed regularly by caregivers adjusting for changes of the end user¿s condition and environmental factors.

Event Description

The reporter stated the therapeutic support surface wasn¿t filling properly and has the service light illuminated resulting in a large wound on the users back area.They stated the wound is at least a stage three and has some bleeding and are getting treatment from doctors three days per week.

• Brand Name: MICROAIR MA600
• Type of Device: THERAPEUTIC SUPPORT SURFACE
• Manufacturer (Section D): CAREMED SUPPLY INC.; lane 235, bao chiao rd.; xin tien, taipei hsian 231 ; TW 231
• Manufacturer (Section G): CAREMED SUPPLY INC.; lane 235, bao chiao rd; xin tien, taipei hsian 231 ; TW 231
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 18110532
• MDR Text Key: 327865567
• Report Number: 1531186-2023-00004
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2023,10/18/2023

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: Lay User/Patient
• Device Model Number: NA:MA600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2023
• Device Age: 23 MO
• Event Location: Home
• Date Report to Manufacturer: 11/08/2023
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male