MAUDE Adverse Event Report: JOERNS HEALTHCARE DOLPHIN FIS MATTRESS; PATIENT AIR MATTRESS

Model Number DLPH-35820000J-M

Device Problem Device Operational Issue (2914)

Patient Problem Death (1802)

Event Date 02/13/2018

Event Type  Death  

Event Description

It was reported to the manufacturer by the end user, per the end user, "sister alleges her brother purchased a dolphin mattress that was defective, (had a hole in it) made him sick, caused him to be hospitalized and resulted in his death." at current, the product has not been confirmed by the manufacturer as a dolphin as the product is still in the families possession.

Manufacturer Narrative

The device was confirmed to be a dolphin fis mattress and control unit.Visual inspection of the product for product identification was performed.The product remains in the families possession.

• Brand Name: DOLPHIN FIS MATTRESS
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7603229
• MDR Text Key: 111113650
• Report Number: 3009402404-2018-00032
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

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: Patient Family Member or Friend
• Device Model Number: DLPH-35820000J-M
• Device Catalogue Number: DLPH-35820000J-M
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 07/05/2018
• 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): Death
• Patient Age: 63 YR