MAUDE Adverse Event Report: MERIDIAN MEDICAL (ROSCO MEDICAL) MERIDIAN LOW AIR LOSS PUMP; AIR MATTRESS CONTROL UNIT

Model Number 4253E

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Physical Entrapment (2327)

Event Date 10/16/2016

Event Type  Death  

Event Description

Pt found dead with head between bed side rail and mattress.

• Brand Name: MERIDIAN LOW AIR LOSS PUMP
• Type of Device: AIR MATTRESS CONTROL UNIT
• Manufacturer (Section D): MERIDIAN MEDICAL (ROSCO MEDICAL); 6753 engle rd.; middleburg heights OH 44130
• MDR Report Key: 6129316
• MDR Text Key: 61016749
• Report Number: 6129316
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/08/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4253E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2016
• Distributor Facility Aware Date: 10/26/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AIR MATTRESS; FULL ELECTRIC BED; GEL CUSHION; OVER THE BED TABLE; OXYGEN CONCENTRATOR; WC
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Weight: 54