MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1733A; VITAL SIGNS MONITOR

Model Number BSM-1733A

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Charging Problem (2892); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2016

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reports that the battery on the bsm (bedside monitor) will not hold a charge.The battery was charged for a full day on a docking station and the battery successfully charged.The customer, however reports that when the bsm is tilted or bumped the unit will power off.Customer states that every time the unit is shaken the issue recurs even though the battery has a full charge.The unit was returned for evaluation and repair.The unit was cleaned and evaluated.The reported problem of unit not holding a charge on the battery was duplicated.This unit came in with physical damage.The power board will need to be a replaced on this unit.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The biomedical engineer reports that the battery on the bsm (bedside monitor) will not hold a charge.The battery was charged for a full day on a docking station and the battery successfully charged.The customer, however reports that when the bsm is tilted or bumped the unit will power off.Customer states that every time the unit is shaken the issue recurs even though the battery has a full charge.

Manufacturer Narrative

Manufacturer narrative: there is no additional information to be provided regarding this device.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: BSM-1733A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 6284954
• MDR Text Key: 66283637
• Report Number: 8030229-2017-00011
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: 04931921111833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/27/2017,12/28/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-1733A
• Device Catalogue Number: BSM-1733A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2017
• Distributor Facility Aware Date: 12/28/2016
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2017
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2014
• 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