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

Model Number CSM-1901

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Bruise/Contusion (1754); Pressure Sores (2326); Patient Problem/Medical Problem (2688)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the spo2 probe, used in conjunction with the bsm (bedside monitor), is stiff and hard.This makes it more difficult for the sensors to keep good contact with the skin, which caused a false alarm.The patients involved in this incident are neonate patients.In order to keep the sensor in place and keep it from raising away from the skin, the customer stretched the tape, used to keep the probe in place, much tighter than is recommended.This resulted in cuts to the babies' skin, due to the probe itself being too rigid.Investigation result (ticket #: (b)(4)): this complaint is regarding spo2 probe causing injuries, not the malfunction of the monitoring device that the probe was connected to.The above incident from ticket (b)(4) was reported on (b)(6) 2018 during a go-live event.There are nine other incidents of injury from this go-live event.The issue is isolated to one customer: sparrow health system (account id (b)(6)).The following is the list of additional tickets related to this incident: (b)(4).From an email by (b)(6), nk clinical applications specialist, on (b)(6) 2018, that during the go-live event, the customer stated the spo2 probes were lasting only three hours without them having to change the probe.This is alluding to the adhesive tape on the probe, although no clarification was provided.The situation became a huge expense to the unit and babies were having to stay longer based on desats that they felt may or may not be real due to the probe coming loose.Customer stated that the probe is stiff and hard which made to more difficult to get the sensors to touch the skin.The tape that came with these probes is very stretchy so they would put the probe on and if the tape was not tight enough the sensor would raise causing a false alarm.They would put the tape on tighter so that the sensor would not raise; this is when it would cause cuts to the babies' skin because the probe itself is hard.Nkc's investigation results did not find issues with the hardness of the sensor area and tape shape for tl-052s.Risk analysis was performed under (b)(4).It was judged that the risk evaluation was acceptable.From the above information, it is concluded that the root cause was due to customer not being familiar with nk spo2 technology and have misused the product.Concomitant medical products: spo2 probe information: model: tl-052s, lot: not provided, expiration date: not provided, unique identifier (udi) #: (b)(4).Is this a single-use device that was reprocessed and reused on a patient? no.Probes used in this incident were not returned.Concomitant medical product: the spo2 probe was used in conjunction with the bedside monitor.Approximate age of device for spo2 probe: probe lot #/expiration not provide.No age of probe available.Device manufacture date for spo2 probe: probe lot #/expiration not provide.No device manufacture date available.Labeled for single use? yes.Usage of device: reuse.The probe is labeled for single use but the customer re-used it a way which resulted in a patient injury.

Event Description

The customer reported that the spo2 probe, used in conjunction with the bsm (bedside monitor), is stiff and hard.This makes it more difficult for the sensors to keep good contact with the skin, which caused a false alarm.The patients involved in this incident are neonate patients.In order to keep the sensor in place and keep it from raising away from the skin, the customer stretched the tape, used to keep the probe in place, much tighter than is recommended.This resulted in cuts to the babies' skin, due to the probe itself being too rigid.

• Brand Name: CSM-1901
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, 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: 9177418
• MDR Text Key: 161969932
• Report Number: 8030229-2019-00533
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2019

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: CSM-1901
• Device Catalogue Number: CSM-1901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2019
• Distributor Facility Aware Date: 05/23/2018
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2019
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2016
• 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