MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number UNKNOWN

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

Patient Problem Skull Fracture (2077)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Arjo was informed about an event involving the enterprise 5000 bed frame and nimbus system (mattress and pump) which were used on a post-natal ward.Following the information gathered, a baby lying on the bed with mother fell out of the bed and sustained a cracked skull.The baby fall was unwitnessed by the facility staff but the mother informed that she fell asleep whilst the baby was in her arms.The safety side rails were in the lowered position at that time.As two arjo devices were involved in the adverse event (nimbus system and enterprise 5000 bed frame), an additional report for the enterprise 5000 bed frame was submitted under number 3007420694-2021-00051.The involved devices have not been checked by the arjo representative as the hospital is conducting its own investigation.The serial numbers were not provided.It was confirmed by the facility that no malfunction of arjo devices was found.Arjo nimbus system was used for a patient treatment when the event occurred and from that perspective, it played a role in the event.No malfunction was reported by the customer.The complaint was decided to be reportable due to the patient's fall which resulted in serious health consequences.

Event Description

Arjo was informed about an event involving the enterprise 5000 bed frame and nimbus system (mattress and pump) which were used on a post-natal ward.Following the information gathered, a baby lying on the bed with mother fell out of the bed and sustained a cracked skull.The baby fall was unwitnessed by the facility staff but the mother informed that she fell asleep whilst the baby was in her arms.The safety side rails were in the lowered position at that time.As two arjo devices were involved in the adverse event (nimbus system and enterprise 5000 bed frame), an additional report for the enterprise 5000 bed frame was submitted under number 3007420694-2021-00051.

• Brand Name: NIMBUS 3 / DFS3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 11647639
• MDR Text Key: 256540810
• Report Number: 3005619970-2021-00009
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2021

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: UNKNOWN
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening; Required Intervention