MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O ALPHA RESPONSE

Model Number 465001DAR

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2014

Event Type  Other  

Event Description

The customer advised mattress keeps over inflating causing his legs to fall off the mattress and get caught in between the mattress and rails.The technician advised no obvious fault.Reference mfr # 3007420694-2014-00071.

• Brand Name: ALPHA RESPONSE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O; ul. ks. piotra warwrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• MDR Report Key: 3952426
• MDR Text Key: 4622186
• Report Number: 1419652-2014-00169
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 465001DAR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2014
• Distributor Facility Aware Date: 04/08/2014
• Event Location: Home
• Date Report to Manufacturer: 06/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other