MAUDE Adverse Event Report: INVACARE MICROAIR APM/LAL PUMP, MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number IINV MA65-P MICROAIR APM/LAL PUMP, MATTRESS MA65 36X80 LALAPM

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

Patient Problem Fall (1848)

Event Date 03/17/2021

Event Type  Injury  

Event Description

Per rn, the patient fell off this mattress the morning of (b)(6) 2021 for the third time.She had fallen off of the lal on to the floor face down while trying to turn herself over.Rn stated that no injuries were reported, and the patient did not require any medical attention.The first fall occurred on (b)(6) 2021 and second time was on (b)(6) 2021.She requested an lal with bolsters to be placed on (b)(6) 2021.She stated an fst called her and said he could place the lal with bolsters until the morning of (b)(6) 2021.Rn works evenings between 4pm -1230am on the 5th floor.She was not working at the facility the morning the lal with bolsters was delivered.She said she did not follow up on the delivery because she forgot.She provided the above assets.I advised her that the patient had two active open orders.She is not sure what happened to the lal mattress that was delivered under order (b)(4) on (b)(6) 2021 with assets of cu (b)(6).I have created a pick-up of (b)(4), a new delivery of (b)(4) and a sweep of (b)(4) for the missing delivery.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MICROAIR APM/LAL PUMP, MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17527913
• MDR Text Key: 321138976
• Report Number: MW5134844
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: IINV MA65-P MICROAIR APM/LAL PUMP, MATTRESS MA65 36X80 LALAPM
• Device Catalogue Number: MATSTD-MA65-P, MA65848
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1