MAUDE Adverse Event Report: CAREMED SUPPLY INC. MICROAIR MA900; THERAPEUTIC SUPPORT SURFACE

Model Number NA:MA900

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

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

The alleged issue of the user falling from the bed while utilizing an ma900 therapeutic support surface and sustaining an intracranial hematoma could not be confirmed, and the underlying cause could not be determined.However, it¿s likely that this either wasn¿t the right product or the right configuration for this user.This device was manufactured by caremed supply.The supplier will be notified of the incident.There was no indication of a malfunction.Therefore, no return of the device is necessary.Per the safety sheet supplied with this device, invacare recommends using this product in conjunction with other invacare devices and accessories.Invacare has not tested this device with any drive products.Invacare suggests rails be present, and raised when the patient is in the bed.

Event Description

The dealer reported that the user slid out of the bed when nobody was around and was taken to the hospital for treatment.The user allegedly sustained an intracranial hematoma.The ma900 was being used on a drive full electric bed.The bed didn¿t have any rails installed, and the rotation of the ma900 was turned on.The user is non-ambulatory and needs full assistance to move.

• Brand Name: MICROAIR MA900
• Type of Device: THERAPEUTIC SUPPORT SURFACE
• Manufacturer (Section D): CAREMED SUPPLY INC.; 7f, no.2 lane 235 bao chiao rd; xin tien city; taipei R.O.C . 23; TW R.O.C. 231
• MDR Report Key: 10244332
• MDR Text Key: 197970954
• Report Number: 1525712-2020-00017
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2020,06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: NA:MA900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2020
• Distributor Facility Aware Date: 06/29/2020
• Device Age: 1 YR
• Date Report to Manufacturer: 07/08/2020
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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): Hospitalization