MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1753A; VITAL SIGNS MONITOR

Model Number BSM-1753A

Device Problems Deflation Problem (1149); Pumping Problem (3016)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the bedside monitor (bsm) non-invasive blood pressure (nibp) pump was inflating all the way to "180" but would not deflate.The customer tried rebooting the transport monitor, checking the cabling and tubing, and changing the cuff, but the problem persisted.The customer sent the unit in for an exchange under warranty.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.The following field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The customer reported that the bedside monitor (bsm) non-invasive blood pressure (nibp) pump was inflating all the way to "180" but would not deflate.

Manufacturer Narrative

Details of complaint: the customer reported that the nibp pump was inflating all the way to "180" on the bedside monitor (bsm) but would not deflate.The customer tried rebooting the transport monitor, checking the cabling and tubing, and changing the cuff, but the problem persisted.The customer sent the unit in for an exchange under warranty.No patient harm or injury was reported.Service requested / performed: evaluation / repair.Investigation summary: the device evaluation indicated that multiple parts of the device were damaged and that the nibp module on the device was unable to maintain pressure because of a broken prong.After the damaged parts were replaced, the issue was resolved.The device was tested and was operating within specifications.Based on the available information, the most probable cause of the issue is physical damage of the device.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The customer reported that the nibp pump was inflating all the way to "180" on the bedside monitor (bsm) but would not deflate.

• Brand Name: BSM-1753A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, 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
• MDR Report Key: 9684742
• MDR Text Key: 204215331
• Report Number: 8030229-2020-00057
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: 4931921111871
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2020,01/16/2023

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-1753A
• Device Catalogue Number: BSM-1753A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2020
• Distributor Facility Aware Date: 01/10/2020
• Device Age: 38 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2020
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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