MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CSM-1901; VITAL SIGNS MONITOR

Model Number CSM-1901

Device Problem Device Alarm System (1012)

Patient Problem Skin Tears (2516)

Event Date 07/18/2023

Event Type  malfunction  

Event Description

The customer reported he sliced his wrist while changing the battery.

Manufacturer Narrative

The customer reported that the battery on this unit was changed out and now it is alarming every 2 minutes with an rsoc unstable error message.The customer reported he sliced his wrist while changing the battery.Technical support (ts) informed the customer that this message shows up when the battery capacity is not where it needs to be.Ts informed the customer that they'll need to let the battery charge overnight and the message should go away.The customer turned off the alarm sound in the meantime.The customer later reported that the battery charged overnight and they have now turned the battery alarm back on.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.

Manufacturer Narrative

Details of complaint: the customer reported that the battery on this unit was changed out and now it is alarming every 2 minutes with an rsoc unstable error message.The customer reported he sliced his wrist while changing the battery.Technical support (ts) informed the customer that this message shows up when the battery capacity is not where it needs to be.Ts informed the customer that they'll need to let the battery charge overnight and the message should go away.The customer turned off the alarm sound in the meantime.The customer later reported that the battery charged overnight and they have now turned the battery alarm back on.Investigation summary: the customer indicated that they had recently replaced the battery of the device.Battery rsoc unstable is an error message that occurs when the charging capacity of the sb-920p battery pack is not accurately detected.It was indicated that the issue was resolved after the battery was charged.The customer reported that they sliced their wrist while replacing the battery.There are 21 complaints made from 01/01/2021 to 10/12/2021 regarding battery issues on the cu-192ra device.Out of the 21 complaints only this ticket has reported an injury while changing the battery.There were no other reports of injury from replacing the battery.The reported issue is likely an isolated incident.A definitive root cause could not be identified.Manufacturer references # (b)(4) follow up 001.

Event Description

The customer reported he sliced his wrist while changing the battery.

• Brand Name: CSM-1901
• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17553241
• MDR Text Key: 321988643
• Report Number: 8030229-2023-03710
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: 04931921112168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151080
• 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: 10/23/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CSM-1901
• Device Catalogue Number: CSM-1901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• 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): Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White