MAUDE Adverse Event Report: SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.,. DRIVE; BED

Model Number	15005L
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/10/2019
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bed.The service provider delivered the unit without the component that elevated the head.The unit was installed incompletely.The first unit provided in hospital was a bed that was too short.This unit was replaced on (b)(6) 2019 with an incomplete bed that was missing the part that elevated the head of bed.The missing piece was scheduled to arrive that night but was delivered on the (b)(6).The patient was suffering from upper respiratory congestion.This condition was further aggravated since the bed was not elevated.The patient could not breathe and died of his own secretions on the night of (b)(6).The diagnosis of his death was respiratory distress.

• Brand Name: DRIVE
• Common Device Name: BED
• Manufacturer (Section D): SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.,.; no. 259 jiugan road; sijing town, song; jiang district, 20160 1; CH 201601
• MDR Report Key: 9448482
• Report Number: 2438477-2019-00082
• Device Sequence Number: 11315189
• Product Code: FNL
• UDI-Device Identifier: 00822383563329
• UDI-Public: 822383563329
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2019
• Report Date (Section F): 12/10/2019

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
• Operator of Device: Health Professional
• Device Model Number: 15005L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/20/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 66 YR
• Date Report Sent to FDA: 12/10/2019