STATIC AIR SEAT CUSHION
Received Feb 9, 2024 · Event occurred Jan 11, 2024
Report 18675531 · MDR key 18675531
Device
Generic name
Protector, Skin Pressure
Manufacturer
Molnlyck Health CareModel number
1400106Catalog number
1400106
Lot number
23410004
Product problems
- Deflation Problem
Patient
78 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WAFFLE CUSHION DEFLATED WHILE PATIENT WAS USING CUSHION IN CHAIR. THE CHAIR CUSHION IS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASES THE RISK FOR PATIENT ACQUIRED PRESSURE INJURIES. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER) EQUIPMENT FAILURE REPORTED TO (B)(4). MANUFACTURER ASSIGNED CASE NUMBER. EQUIPMENT SENT OUT. -COMPLAINT SAMPLES IIMED VIA FEDEX.
Description of Event or Problem
WAFFLE CUSHION DEFLATED WHILE PATIENT WAS USING CUSHION IN CHAIR. THE CHAIR CUSHION IS UTILIZED FOR PRESSURE REDUCTION FOR SKIN CARE. IF THIS PRODUCT IS DEFLATED, IT INCREASES THE RISK FOR PATIENT ACQUIRED PRESSURE INJURIES. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, STATIC AIR SEAT CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO COMPLAINTS.US@MOLNKLYCKE.COM. MANUFACTURER ASSIGNED CASE NUMBER. EQUIPMENT SENT OUT. COMPLAINT SAMPLES IIMED VIA FEDEX.