MAUDE Adverse Event Report: EEZCARE MEDICAL CORP. MERIDIAN; 8" APM-8LPM PUMP W/FOAM BASE

Model Number MER-4500

Device Problem Insufficient Information (3190)

Patient Problem Localized Skin Lesion (4542)

Event Type  Injury  

Event Description

Notified 02/15/2023: customer called in stating he received his bed in july of 2022 after he got out of rehab for back surgery.When he laid down on it he said that it didn't feel right.He said that he wasn't feeling the alternating of the air in the mattress.He says that shortly after (he's not exactly sure how much time after) his nurse found a red spot on his back which turned into a sore about the size of a baseball.He states that his skin is very sensitive and it is not healing properly and just recently reopened and is not going away.He says that his nurse and doctors have been trying different methods to make this heal.After finding out about the sore he called the pharmacy who are the ones who sent the tech out to put the bed together to have them come out and look at it.They opened the mattress cover and noticed that the inside was put in upside down and that he had been laying on the tubing instead.He said the tech didn't know how to correct this, but he figured out how to turn this around.Customer states that he thinks the bed was not manufactured incorrectly, just that the tech put it together wrong.He states that the pharmacy is taking no responsibility in this situation and will not help him.He is looking for compensation but didn't say what it was he wanted.He said that the pharmacy told him that he should sue us because they are claiming it is a manufacturing defect.Spoke with the service manager, from the pharmacy regarding the alleged incident.He did recall the situation, stating his technician communicated upon return that the baffles were installed upside down inside the cover, so he was laying on the tubing.He said he asked his technician if the whole mattress was installed upside down and that he said no, only the inner baffles within the mattress.I asked if they still had the unit and was told no, they tossed it out in the dumpster.I asked if they by chance took any photos of this condition or had a service report noting service provided they'd be able to share? the answer was no but he would ask the technician if he took any photos when he returned from the field and call me back later today.They were not able to confirm the model number of the apm involved in the incident or new unit installed.Additionally, i asked if by chance they called compass health's customer service to report the incident and request a replacement unit? he said no they did not.Director, product management - hme and director of quality compliance discussed the service managers feedback regarding the "baffles being installed upside down and that was the reason he was laying on the tubing" and both of us are confused by this statement as the airflow tubing from the pump only runs along the side of the apm mattress system.The individual air cell connects from the side/edge of air cell to the tubing running down the side of the mattress cover (one side only).There is no tubing running through the center of any air cell structure that could come in contact with the patient during normal use.Even if an air cell collapsed the patient would not find themselves laying on the side/edge air tubing.They would most likely be in contact with the bed spring system.Notified 04/04/2023: per claims: i just got off the phone with the end-user.He is currently in the hospital after having plastic surgery due to the sore he developed.He will then go to rehab for 6 weeks.He said he has a written statement from the person who put the bed together saying it was the manufactures fault.

Event Description

Correction to item number.

Event Description

Correct item number received.

Event Description

Update: 1.Who (technician name) initially delivered & installed the product to the customer? gary greiwe a.Was this product new out-of-box? or previously used? new out of the box b.Does he / she have experience with this product? yes, (b)(6) has been with the company since (b)(6) 2019 and does quarterly trainings on products as well as hippa and other necessary trainings.Per gary, he has setup a lot of these and would guess he has setup anywhere from 60 to 100 of these.2.Date product was initially delivered/installed? (b)(6) 2022.3.When were you first made aware of an issue with the product after installation? (date) (b)(6) 2022.A.Is the technician you sent out to inspect the product the same person who installed the product? yes, (b)(6).B.Do you have a copy of the service/inspection incident report you can share? attached is the incident report as well as the delivery ticket, and pickup ticket.C.Did you replace with the same compass health brands model number? or a different brand/model? no, since insurance paid for the mattress end user and his wife did not want it swapped out.His wife flipped the mattress and didn't want us to do anything but pick up the bed and they would keep the air mattress.4.Do you still have the product involved in this incident? no, end user has the mattress a.If not, where is the product involved in this incident located? i believe it is still at their residence.We do not have it.

• Brand Name: MERIDIAN
• Type of Device: 8" APM-8LPM PUMP W/FOAM BASE
• Manufacturer (Section D): EEZCARE MEDICAL CORP.; no. 3-1, minquan st; tucheng dist; new taipei city, tw 23679 ; TW 23679
• MDR Report Key: 16723799
• MDR Text Key: 313138319
• Report Number: 3012316249-2023-00007
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2023

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: MER-4500
• 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: 06/13/2023
• Distributor Facility Aware Date: 04/04/2023
• Device Age: 23 MO
• Event Location: Home
• Date Report to Manufacturer: 06/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/06/2023; 06/13/2023; 06/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 57 KG