MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 5000; BED, AC-POWERED ADJUSTABLE HOSPITAL

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

Patient Problem Skull Fracture (2077)

Event Type  Injury  

Manufacturer Narrative

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 enterprise 5000 bed 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 nimbus system was submitted under numer 3005619970-2021-00009.

• Brand Name: ENTERPRISE 5000
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 11647590
• MDR Text Key: 256518513
• Report Number: 3007420694-2021-00051
• Device Sequence Number: 1
• Product Code: FNL
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 03/17/2021
• 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